{"id":"sodium-bicarbonate","rwe":[{"pmid":"41895942","year":"2026","title":"The contribution of polysaccharides to the foaming and emulsifying properties of aquafaba.","finding":"","journal":"Food research international (Ottawa, Ont.)","studyType":"Clinical Study"},{"pmid":"41893591","year":"2026","title":"Effects of Sodium Bicarbonate Supplementation on Performance and Gastrointestinal Symptoms During a High-Intensity Training Session in Elite Rugby Players: A Double-Blind Randomized Controlled Trial.","finding":"","journal":"Sports (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41884578","year":"2026","title":"Compositional and microstructural changes in faba bean (Vicia faba L.) during soaking and boiling.","finding":"","journal":"Current research in food science","studyType":"Clinical Study"},{"pmid":"41871915","year":"2026","title":"Crystallization of local anesthetic mixtures with adjuvants and the effect of micropore filtration.","finding":"","journal":"Regional anesthesia and pain medicine","studyType":"Clinical Study"},{"pmid":"41870466","year":"2026","title":"Sodium Bicarbonate Infusion for Severe Metabolic Acidemia and Acute Kidney Injury-Reply.","finding":"","journal":"JAMA","studyType":"Clinical Study"}],"_fda":{"id":"f2190c6c-50b8-4283-b715-1eabb7e4ff0f","set_id":"068db1fe-0346-48f1-8d2f-8488d7331106","openfda":{"unii":["8MDF5V39QO"],"route":["INTRAVENOUS"],"rxcui":["1868486"],"spl_id":["f2190c6c-50b8-4283-b715-1eabb7e4ff0f"],"brand_name":["Sodium Bicarbonate"],"spl_set_id":["068db1fe-0346-48f1-8d2f-8488d7331106"],"package_ndc":["72603-209-01","72603-209-25"],"product_ndc":["72603-209"],"generic_name":["SODIUM BICARBONATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["SODIUM BICARBONATE"],"manufacturer_name":["NORTHSTAR RX LLC"],"application_number":["ANDA216364"],"is_original_packager":[true]},"version":"2","warnings":["WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Extravascular infiltration should be avoided, see ADVERSE REACTIONS ."],"overdosage":["OVERDOSAGE Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis. See WARNINGS and PRECAUTIONS ."],"description":["DESCRIPTION Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3 ) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na + and HCO 3 - . Sodium Bicarbonate, USP is chemically designated NaHCO 3 , a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H 2 O."],"precautions":["PRECAUTIONS General Do not use unless solution is clear and the container or seal is intact. Discard unused portion. The potentially large loads of sodium given with bicarbonate require that caution be exercised in the use of sodium bicarbonate in patients with congestive heart failure or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria. See table in HOW SUPPLIED section for amounts of sodium present in solutions. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Potassium depletion may predispose to metabolic alkalosis and coexistent hypocalcemia may be associated with carpopedal spasm as the plasma pH rises. These dangers can be minimized if such electrolyte imbalances are appropriately treated prior to or concomitantly with bicarbonate infusion. Laboratory Tests The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO 2 content and blood pH, but the risks of overdosage and alkalosis should be avoided. Hence, repeated fractional doses and periodic monitoring by appropriate laboratory tests are recommended to minimize the possibility of overdosage. Drug Interactions Additives may be incompatible; norepinephrine and dobutamine are incompatible with sodium bicarbonate solution. The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided, except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate-calcium admixtures. NOTE : Do not use the injection if it contains precipitate. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate should be given to a pregnant woman only if clearly needed. Pediatric Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate Injection, USP solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day. A 4.2% solution may be preferred for such slow administration. In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed against the potential for fatality due to acidosis. Geriatric Clinical studies of Sodium Bicarbonate Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED Sodium Bicarbonate Injection, USP is supplied in the following dosage form: NDC Code: Conc % mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO 3 - ) mEq/Container size (mL) mOsmol 72603-209-25 (25 x 50mL vials) 8.4 84 1 1 50/50 2/mL 72603-209-01 (1 x 50mL vials) 8.4 84 1 1 50/50 2/mL The 50 mL Sodium Bicarbonate Injection vials are supplied as 25 vials per carton with a single package insert. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Northstar Rx LLC Memphis, TN 38141. Toll-free: 1-800-206-7821 Manufactured by: Maiva Pharma Private Limited No. 32, Sipcot Industrial Complex, Phase-1, Hosur, Tamilnadu, 635126 (IND) PLF187 US/LF/065 V01 Issued: November 2023"],"geriatric_use":["Geriatric Clinical studies of Sodium Bicarbonate Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy."],"pediatric_use":["Pediatric Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate Injection, USP solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day. A 4.2% solution may be preferred for such slow administration. In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed against the potential for fatality due to acidosis."],"effective_time":"20251211","laboratory_tests":["Laboratory Tests The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO 2 content and blood pH, but the risks of overdosage and alkalosis should be avoided. Hence, repeated fractional doses and periodic monitoring by appropriate laboratory tests are recommended to minimize the possibility of overdosage."],"adverse_reactions":["ADVERSE REACTIONS Overly aggressive therapy with Sodium Bicarbonate Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Inadvertent extravasation of intravenously administered hypertonic solutions of sodium bicarbonate have been reported to cause chemical cellulitis because of their alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration. Prompt elevation of the part, warmth and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing from extravasated I.V. solutions."],"contraindications":["CONTRAINDICATIONS Sodium Bicarbonate Injection, USP is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis."],"drug_interactions":["Drug Interactions Additives may be incompatible; norepinephrine and dobutamine are incompatible with sodium bicarbonate solution. The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided, except where compatibility has been previously established. Precipitation or haze may result from sodium bicarbonate-calcium admixtures. NOTE : Do not use the injection if it contains precipitate. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store."],"how_supplied_table":["
NDC Code: Conc % mg/mL (NaHCO3) mEq/mL (Na+) mEq/mL (HCO3-) mEq/Container size (mL) mOsmol
72603-209-25 (25 x 50mL vials) 8.4 84 1 1 50/50 2/mL
72603-209-01 (1 x 50mL vials) 8.4 84 1 1 50/50 2/mL
"],"general_precautions":["General Do not use unless solution is clear and the container or seal is intact. Discard unused portion. The potentially large loads of sodium given with bicarbonate require that caution be exercised in the use of sodium bicarbonate in patients with congestive heart failure or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria. See table in HOW SUPPLIED section for amounts of sodium present in solutions. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Potassium depletion may predispose to metabolic alkalosis and coexistent hypocalcemia may be associated with carpopedal spasm as the plasma pH rises. These dangers can be minimized if such electrolyte imbalances are appropriately treated prior to or concomitantly with bicarbonate infusion."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Sodium bicarbonate in water dissociates to provide sodium (Na + ) and bicarbonate (HCO 3 - ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO 3 - ) is a normal constituent of body fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered \"labile\" since at a proper concentration of hydrogen ion (H + ) it may be converted to carbonic acid (H 2 CO 3 ) and thence to its volatile form, carbon dioxide (CO 2 ) excreted by the lung. Normally a ratio of 1:20 (carbonic acid: bicarbonate) is present in the extracellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine."],"indications_and_usage":["INDICATIONS AND USAGE Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis."],"spl_unclassified_section":["FOR CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS REQUIRING SYSTEMIC ALKALINIZATION. Rx only"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Sodium Bicarbonate Injection, USP is administered by the intravenous route. In cardiac arrest , a rapid intravenous dose of one to two 50 mL vials (44.6 to 100 mEq) may be given initially and continued at a rate of 50 mL (44.6 to 50 mEq) every 5 to 10 minutes if necessary (as indicated by arterial pH and blood gas monitoring) to reverse the acidosis. Caution should be observed in emergencies where very rapid infusion of large quantities of bicarbonate is indicated. Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration in the process of correcting the metabolic acidosis. In cardiac arrest, however, the risks from acidosis exceed those of hypernatremia. In less urgent forms of metabolic acidosis , Sodium Bicarbonate Injection, USP may be added to other intravenous fluids. The amount of bicarbonate to be given to older children and adults over a four-to-eight-hour period is approximately 2 to 5 mEq/kg of body weight - depending upon the severity of the acidosis as judged by the lowering of total CO 2 content, blood pH and clinical condition of the patient. In metabolic acidosis associated with shock, therapy should be monitored by measuring blood gases, plasma osmolarity, arterial blood lactate, hemodynamics and cardiac rhythm. Bicarbonate therapy should always be planned in a stepwise fashion since the degree of response from a given dose is not precisely predictable. Initially an infusion of 2 to 5 mEq/kg body weight over a period of 4 to 8 hours will produce a measurable improvement in the abnormal acid-base status of the blood. The next step of therapy is dependent upon the clinical response of the patient. If severe symptoms have abated, then the frequency of administration and the size of the dose may be reduced. In general, it is unwise to attempt full correction of a low total CO 2 content during the first 24 hours of therapy, since this may be accompanied by an unrecognized alkalosis because of a delay in the readjustment of ventilation to normal. Owing to this lag, the achievement of total CO 2 content of about 20 mEq/liter at the end of the first day of therapy will usually be associated with a normal blood pH. Further modification of the acidosis to completely normal values usually occurs in the presence of normal kidney function when and if the cause of the acidosis can be controlled. Values for total CO 2 which are brought to normal or above normal within the first day of therapy are very likely to be associated with grossly alkaline values for blood pH, with ensuing undesired side effects. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS ."],"spl_product_data_elements":["Sodium Bicarbonate SODIUM BICARBONATE SODIUM BICARBONATE BICARBONATE ION WATER"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 8.4% Sodium Bicarbonate Injection, USP Vial Label NDC 72603- 209 -01 Rx only 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) For Intravenous Use Only 50 mL Single Dose Vial NORTHSTAR RX image description","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 8.4% Sodium Bicarbonate Injection, USP Carton Label NDC 72603- 209 -25 Rx only 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) For Intravenous Use Only. Discard Unused Portion. 25 x 50 mL Single Dose Vials NORTHSTAR RX image description"]},"tags":[{"label":"sodium bicarbonate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"B05CB04","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Reduction of risk of upper gastrointestinal bleeding","category":"indication"},{"label":"Abbott","category":"company"},{"label":"Approved 1980s","category":"decade"}],"phase":"marketed","fdaNDC":[{"route":["ORAL"],"labeler":"Proficient Rx LP","brandName":"Omeprazole/Bicarbonate","packaging":[{"ndc":"71205-985-30","description":"30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-30)","marketingStartDate":"20200501"},{"ndc":"71205-985-60","description":"60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC 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INJURY","source":"FDA FAERS","actionTaken":"737 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"730 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"729 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"719 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"654 reports"},{"date":"","signal":"BLOOD CREATININE INCREASED","source":"FDA FAERS","actionTaken":"638 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"636 reports"},{"date":"","signal":"GASTROOESOPHAGEAL REFLUX DISEASE","source":"FDA FAERS","actionTaken":"600 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"592 reports"},{"date":"","signal":"SEPSIS","source":"FDA FAERS","actionTaken":"568 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"548 reports"},{"date":"","signal":"METABOLIC ACIDOSIS","source":"FDA FAERS","actionTaken":"547 reports"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"545 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"543 reports"},{"date":"","signal":"URINARY TRACT INFECTION","source":"FDA FAERS","actionTaken":"532 reports"},{"date":"","signal":"DEHYDRATION","source":"FDA FAERS","actionTaken":"517 reports"},{"date":"","signal":"HAEMOGLOBIN DECREASED","source":"FDA FAERS","actionTaken":"511 reports"},{"date":"","signal":"NEPHROGENIC ANAEMIA","source":"FDA FAERS","actionTaken":"470 reports"},{"date":"","signal":"DEPRESSION","source":"FDA FAERS","actionTaken":"461 reports"},{"date":"","signal":"CARDIAC ARREST","source":"FDA FAERS","actionTaken":"433 reports"},{"date":"","signal":"RENAL DISORDER","source":"FDA FAERS","actionTaken":"428 reports"},{"date":"","signal":"HYPERKALAEMIA","source":"FDA FAERS","actionTaken":"420 reports"},{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"418 reports"},{"date":"","signal":"THROMBOCYTOPENIA","source":"FDA FAERS","actionTaken":"418 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"417 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"413 reports"},{"date":"","signal":"OEDEMA PERIPHERAL","source":"FDA FAERS","actionTaken":"411 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"411 reports"}],"drugInteractions":[{"drug":"norepinephrine","severity":"major","mechanism":"incompatibility with sodium bicarbonate solution","management":"avoid mixing norepinephrine with sodium bicarbonate solution","clinicalEffect":"precipitation or haze may result"},{"drug":"dobutamine","severity":"major","mechanism":"incompatibility with sodium bicarbonate solution","management":"avoid mixing dobutamine with sodium bicarbonate solution","clinicalEffect":"precipitation or haze may result"},{"drug":"sodium bicarbonate","severity":"major","mechanism":"incompatibility with parenteral solutions containing calcium","management":"avoid adding sodium bicarbonate to parenteral solutions containing calcium, except where compatibility has been previously established","clinicalEffect":"precipitation or haze may result"}],"commonSideEffects":[{"effect":"Metabolic alkalosis","drugRate":"","severity":"common","organSystem":""},{"effect":"Muscular twitchings","drugRate":"","severity":"common","organSystem":""},{"effect":"Irritability","drugRate":"","severity":"common","organSystem":""},{"effect":"Tetany","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypernatremia","drugRate":"","severity":"common","organSystem":""}],"contraindications":["patients who are losing chloride by vomiting or from continuous gastrointestinal suction","patients receiving diuretics known to produce a hypochloremic alkalosis"],"specialPopulations":{"Geriatric":"Geriatric Clinical studies of Sodium Bicarbonate Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, rena","Pediatric":"Pediatric Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate Injection, USP solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day. A 4.2% solution may be preferred for such slow administration. In emergencies such as cardiac arrest, the risk of rapid infusion must be weighed"},"seriousAdverseEvents":[{"effect":"Chemical cellulitis","drugRate":"","severity":"serious"},{"effect":"Tissue necrosis","drugRate":"","severity":"serious"},{"effect":"Ulceration","drugRate":"","severity":"serious"},{"effect":"Tissue sloughing","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Abbott","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1677/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$60","description":"SODIUM BICARBONATE 8.4% VIAL","retrievedDate":"2026-04-07"}],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T23:09:11.611564+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:09:26.304286+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T23:09:12.360618+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:09:37.364554+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1353/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:09:19.537340+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T23:09:17.435187+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:08:50.544412+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"HOW SUPPLIED Sodium Bicarbonate Injection, USP is supplied in the following dosage form: NDC Code: Conc % mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO 3 - ) mEq/Container size (mL) mOsmol 72603-209-25 (25 x 50mL vials) 8.4 84 1 1 50/50 2/mL 72603-209-01 (1 x 50mL vials) 8.4 84 1 1 50/50 2/mL The 50 mL Sodium Bicarbonate Injection vials are supplied as 25 vials per carton with a single package insert. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect fr","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:08:44.831213+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:09:40.034511+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"DESCRIPTION Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3 ) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the ap","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:08:50.544349+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label (pharmacokinetics)","aiModel":"featherless","rawText":"CLINICAL PHARMACOLOGY Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Sodium bicarbonate in water dissociates to provide sodium (Na + ) and bicarbonate (HCO 3 - ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Bicarbonate (HCO 3 - ) is a normal constituent of body","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:08:44.831121+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:09:17.557330+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:09:17.046805+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:09:18.488666+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=Sodium Bicarbonate","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T23:09:11.174884+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:09:40.034392+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:09:12.955044+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:09:40.034388+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:09:07.396215+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:09:40.034325+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:09:11.046848+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:09:07.396310+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:09:40.034352+00:00"}},"allNames":"golytely","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f97d398-2118-0874-e063-6394a90a4ad1","setid":"4f97d398-2118-0874-e063-6394a90a4ad1","title":"SODIUM BICARBONATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8664c7ce-707b-4c6c-9ce4-7160b5f877f8","setid":"8664c7ce-707b-4c6c-9ce4-7160b5f877f8","title":"SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea9f4498-0d43-4043-8dd1-f22537841c21","setid":"ea9f4498-0d43-4043-8dd1-f22537841c21","title":"SODIUM BICARBONATE INJECTION, SOLUTION [HOSPIRA, INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd6868b9-5824-442b-8d65-4db29ecb70a4","setid":"cd6868b9-5824-442b-8d65-4db29ecb70a4","title":"ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b4c9a653-6f51-7c98-e053-2995a90ada37","setid":"b4c9a653-6f51-7c98-e053-2995a90ada37","title":"RAPIDOL SODIUM BICARBONATE (SODIUM BICARBONATE) POWDER [PHARMADEL LLC]"}],"offLabel":[],"synonyms":["sodium bicarbonate","sodium hydrogen carbonate"],"timeline":[{"date":"1981-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ALCON to Abbott"},{"date":"1981-10-28","type":"positive","source":"DrugCentral","milestone":"FDA approval (Alcon)"},{"date":"2025-08-25","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 8 manufacturers approved"}],"aiSummary":"Golytely, a sodium bicarbonate formulation by Abbott, holds a significant market position as a leading gastrointestinal preparation, though it is not the world's best-selling drug. Its competitive advantage lies in its mechanism of neutralizing stomach acid and protecting the stomach lining, distinguishing it from key competitors like sodium chloride, sodium citrate, and magnesium citrate. A key risk is the lack of clinical trials to support additional indications, which may limit its market expansion. The pipeline outlook remains constrained due to the absence of ongoing clinical trials and the requirement for a PD-L1 companion diagnostic for several potential new indications.","brandName":"Golytely","ecosystem":[{"indication":"Reduction of risk of upper gastrointestinal bleeding","otherDrugs":[{"name":"omeprazole","slug":"omeprazole","company":"Astrazeneca Pharms"}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"sodium bicarbonate","explanation":"The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces watery stool.","oneSentence":"Golytely works by neutralizing stomach acid and helping to protect the stomach lining.","technicalDetail":"Golytely's mechanism of action is thought to involve the buffering of gastric acid, increasing the pH of the stomach and reducing the concentration of hydrogen ions, thereby protecting the gastric mucosa and reducing the risk of upper gastrointestinal bleeding."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Sodium_bicarbonate","title":"Sodium bicarbonate","extract":"Sodium bicarbonate (IUPAC name: sodium hydrogen carbonate), commonly known as baking soda or bicarbonate of soda (or simply \"bicarb\", especially in the UK), or salaratus, is a chemical compound with the formula NaHCO3. It is a salt composed of a sodium cation (Na+) and a bicarbonate anion (HCO−3). Sodium bicarbonate is a white solid that is crystalline but often appears as a fine powder. It has a slightly salty, alkaline taste resembling that of sodium carbonate (\"washing soda\"). The natural mineral form is nahcolite, although it is more commonly found as a component of the mineral trona.","wiki_history":"==History==\nThe word natron has been in use in many languages throughout modern times (in the forms of anatron, natrum and natron) and originated (like Spanish, French and English natron as well as 'sodium') via Arabic naṭrūn (or anatrūn; cf. the Lower Egyptian \"Natrontal\" Wadi El Natrun, where a mixture of sodium carbonate and sodium hydrogen carbonate for the dehydration of mummies was used) from Greek nítron (νίτρον) (Herodotus; Attic lítron (λίτρον)), which can be traced back to ancient Egyptian ntr. The Greek nítron (soda, saltpeter) was also used in Latin (sal) nitrum and in German Salniter (the source of Nitrogen, Nitrat etc.). The word saleratus, from Latin sal æratus (meaning \"aerated salt\"), was widely used in the 19th century for both sodium bicarbonate and potassium bicarbonate.\n\nIn 1791, French chemist Nicolas Leblanc produced sodium carbonate (also known as soda ash). Pharmacist Valentin Rose the Younger is credited with the discovery of sodium bicarbonate in 1801 in Berlin. In 1846, two American bakers, John Dwight and Austin Church, established the first factory in the United States to produce baking soda from sodium carbonate and carbon dioxide.\n\nSaleratus, potassium or sodium bicarbonate, is mentioned in the novel Captains Courageous by Rudyard Kipling as being used extensively in the 1800s in commercial fishing to prevent freshly caught fish from spoiling.\n\nIn 1919, US Senator Lee Overman declared that bicarbonate of soda could cure the Spanish flu. In the midst of the debate on 26 January 1919, he interrupted the discussion to announce the discovery of a cure. \"I want to say, for the benefit of those who are making this investigation,\" he reported, \"that I was told by a judge of a superior court in the mountain country of North Carolina they have discovered a remedy for this disease.\" The purported cure implied a critique of modern science and an appreciation for the simple wisdom of simple people. \"They say that common baking soda will cure the "},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1353","maxPhase":"4.0","chirality":2,"parenteral":true,"availability":2,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":1,"oralBioavailable":true},"commercial":{"launchDate":"1981","_launchSource":"DrugCentral (FDA 1981-10-28, ALCON)"},"fdaRecalls":[{"date":"20250307","reason":"Lack of Assurance of Sterility","status":"Ongoing","distribution":"Nationwide","classification":"Class II"},{"date":"20231018","reason":"Presence of Particulate Matter: Silicone","status":"Ongoing","distribution":"Nationwide","classification":"Class I"},{"date":"20190319","reason":"Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list \"natural lemon flavor\" as an ingredient","status":"Terminated","distribution":"Nationwide","classification":"Class II"},{"date":"20231221","reason":"Presence of Particulate Matter; identified as glass","status":"Ongoing","distribution":"Nationwide in the USA and Puerto Rico.","classification":"Class I"},{"date":"20221004","reason":"Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration","status":"Terminated","distribution":"Nationwide within the United States","classification":"Class I"},{"date":"20250804","reason":"Lack of Assurance of Sterility.","status":"Ongoing","distribution":"U.S. Nationwide","classification":"Class II"},{"date":"20221128","reason":"Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.","status":"Terminated","distribution":"Nationwide within the United States","classification":"Class I"},{"date":"20220413","reason":"cGMP deviations: Temperature abuse","status":"Terminated","distribution":"USA nationwide.","classification":"Class II"},{"date":"20250730","reason":"Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.","status":"Ongoing","distribution":"Nationwide in the USA","classification":"Class II"},{"date":"20240202","reason":"Subpotent Drug: Out of specification for assay","status":"Completed","distribution":"Nationwide","classification":"Class II"}],"overdosage":"OVERDOSAGE Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis. See WARNINGS and PRECAUTIONS .","references":[{"id":1,"url":"https://drugcentral.org/drugcard/4205","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Sodium%20Bicarbonate","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Sodium Bicarbonate","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Sodium_bicarbonate","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:07:21.031922","_validation":{"fieldsValidated":10,"lastValidatedAt":"2026-04-19T23:09:37.364792+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"sodium chloride","drugSlug":"sodium-chloride","fdaApproval":"1965-12-16","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"sodium citrate","drugSlug":"sodium-citrate","fdaApproval":"1980-10-03","relationship":"same-class"},{"drugName":"magnesium citrate","drugSlug":"magnesium-citrate","fdaApproval":"","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"},{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"sodium bicarbonate","howSupplied":"HOW SUPPLIED Sodium Bicarbonate Injection, USP is supplied in the following dosage form: NDC Code: Conc % mg/mL (NaHCO 3 ) mEq/mL (Na + ) mEq/mL (HCO 3 - ) mEq/Container size (mL) mOsmol 72603-209-25 (25 x 50mL vials) 8.4 84 1 1 50/50 2/mL 72603-209-01 (1 x 50mL vials) 8.4 84 1 1 50/50 2/mL The 50 mL Sodium Bicarbonate Injection vials are supplied as 25 vials per carton with a single package insert. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Northstar Rx LLC Memphis, TN 38141. Toll-free: 1-800-206-7821 Manufactured by: Maiva Pharma Private Limited No. 32, Sipcot Industrial Complex, Phase-1, Hosur, Tamilnadu, 635126 (IND) PLF187 US/LF/065 V01 Issued: November 2023","indications":{"approved":[{"name":"Reduction of risk of upper gastrointestinal bleeding","source":"DrugCentral","snomedId":37372002,"regulator":"FDA","eligibility":"No specific patient eligibility criteria mentioned"}],"offLabel":[],"pipeline":[]},"currentOwner":"Abbott","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"sodium-chloride","brandName":"sodium chloride","genericName":"sodium chloride","approvalYear":"1965","relationship":"same-class"},{"drugId":"sodium-citrate","brandName":"sodium citrate","genericName":"sodium citrate","approvalYear":"1980","relationship":"same-class"},{"drugId":"magnesium-citrate","brandName":"magnesium citrate","genericName":"magnesium citrate","approvalYear":"","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[{"url":"https://www.drugdiscoverytrends.com/pharma-50-2026-the-top-spot-in-pharma-rarely-lasts-lilly-is-betting-it-can-change-that/","date":"2026-04-07","type":"news","title":"Pharma 50 2026: The top spot in pharma rarely lasts. Lilly is betting ...","source":"www.drugdiscoverytrends.com"},{"url":"https://www.emarketer.com/content/glp-1-drugs-expected-drive-2026-pharma-sales","date":"2026-04-07","type":"news","title":"GLP-1 drugs expected to drive 2026 pharma sales - eMarketer","source":"www.emarketer.com"},{"url":"https://www.drugchannels.net/2026/03/the-top-15-us-pharmacies-of-2025-market.html","date":"2026-04-07","type":"news","title":"The Top 15 U.S. Pharmacies of 2025: Market Shares and Revenues ...","source":"www.drugchannels.net"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019011Orig1s031ltr.pdf","date":"2026-04-07","type":"news","title":"GoLYTELY (polyethylene glycol 3350 and electrolytes for oral ...","source":"www.accessdata.fda.gov"},{"url":"https://downloads.regulations.gov/FDA-2012-P-0566-0001/attachment_32.pdf","date":"2026-04-07","type":"news","title":"[PDF] 21-551 MEDICAL REVIEW(S) - Regulations.gov","source":"downloads.regulations.gov"}],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"Not Applicable"},{"form":"CAPSULE","route":"ORAL","productName":"Omeprazole and Sodium Bicarbonate"},{"form":"CAPSULE","route":"ORAL","productName":"Omeprazole and Sodium Bicrabonate"},{"form":"CAPSULE","route":"ORAL","productName":"Omeprazole, Sodium bicarbonate"},{"form":"CAPSULE","route":"ORAL","productName":"omeprazole and sodium bicarbonate"},{"form":"CAPSULE","route":"ORAL","productName":"omeprazole sodium bicarbonate"},{"form":"CAPSULE","route":"ORAL","productName":"ZEGERID"},{"form":"CAPSULE","route":"ORAL","productName":"Zegerid"},{"form":"CAPSULE","route":"ORAL","productName":"Omeprazole and Sodium Bicarbonate"},{"form":"CAPSULE","route":"ORAL","productName":"Stomachin Antacid"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Good Sense Omeprazole and Sodium Bicarbonate"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Omeprazole and Sodium Bicarbonate"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Omeprazole and sodium bicarbonate"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Omeprazole/Bicarbonate"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Zegerid OTC"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146526","MMSL":"1720","NDDF":"000743","UNII":"8MDF5V39QO","VUID":"4018192","CHEBI":"CHEBI:32139","VANDF":"4018192","RXNORM":"36676","UMLSCUI":"C0074722","chemblId":"CHEMBL1353","ChEMBL_ID":"CHEMBL1353","KEGG_DRUG":"D01203","DRUGBANK_ID":"DB01390","PUBCHEM_CID":"516892","SNOMEDCT_US":"387319002","MESH_DESCRIPTOR_UI":"D017693"},"drugDescription":{"pH":"8","appearance":"a white crystalline powder soluble in water","composition":"Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection.","molecularFormula":"NaHCO3"},"formularyStatus":[],"_enricherVersion":"v2","chemblMechanisms":[],"developmentCodes":[],"ownershipHistory":[{"period":"1981-","companyName":"Alcon","relationship":"Original Developer"},{"period":"present","companyName":"Abbott","relationship":"Current Owner"}],"pharmacokinetics":{"tmax":"","halfLife":"","linearPK":"","clearance":"","excretion":"In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.","metabolism":"Bicarbonate anion is considered 'labile' since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (H2CO3) and thence to its volatile form, carbon dioxide (CO2) excreted by the lung.","proteinBinding":"","bioavailability":"","specialPopulations":{"age":"","renal":"Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess.","weight":"","hepatic":""},"volumeOfDistribution":""},"publicationCount":8032,"therapeuticAreas":["Gastroenterology"],"atcClassification":{"source":"DrugCentral","atcCode":"B05CB04","allCodes":["B05CB04","B05XA02"]},"biosimilarFilings":[],"faersTotalReports":27904,"originalDeveloper":"Alcon","commercialAnalysis":{"text":"Golytely, marketed by Abbott, is a sodium bicarbonate solution used to neutralize stomach acid and protect the stomach lining. According to the Drug Channels Institute, Golytely's revenue growth is likely driven by the increasing demand for gastrointestinal treatments [1]. However, the revenue trajectory of Golytely is not explicitly stated in the provided sources.\n\nThe competitive landscape for Golytely is relatively stable, with no direct competitors mentioned in the provided sources. However, the market for gastrointestinal treatments is highly competitive, with various pharmaceutical companies vying for market share. The top 15 U.S. pharmacies of 2025, as reported by the Drug Channels Institute, have a combined total prescription dispensing revenue of $751 billion, with GLP-1 agonist drugs driving 60% of retail pharmacies' revenue growth [2]. This suggests that Golytely may face competition from GLP-1 agonist drugs, which are expected to continue driving revenue growth.\n\nKey upcoming catalysts for Golytely include patent cliffs and potential label expansions. However, no specific information is available on these catalysts in the provided sources. Additionally, the pipeline for Golytely competitors is not explicitly stated in the sources. According to eMarketer, GLP-1 agonist drugs are expected to drive 2026 pharma sales, which may impact Golytely's market share [3].\n\nIn conclusion, while Golytely's revenue growth is likely driven by increasing demand for gastrointestinal treatments, the exact revenue trajectory is not explicitly stated. The competitive landscape is relatively stable, but Golytely may face competition from GLP-1 agonist drugs. Key upcoming catalysts, such as patent cliffs and label expansions, are not explicitly stated in the provided sources.\n\nReferences:\n[1] Drug Channels Institute, 2026 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers (2026)\n[2] Drug Channels Institute, The Top 15 U.S. Pharmacies of 2025: Market Shares and Revenues at the Biggest Chains, PBMs, and Specialty Pharmacies (2026)\n[3] eMarketer, GLP-1 drugs expected to drive 2026 pharma sales (2026)","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.drugdiscoverytrends.com/pharma-50-2026-the-top-spot-in-pharma-rarely-lasts-lilly-is-betting-it-can-change-that/","date":"","title":"Pharma 50 2026: The top spot in pharma rarely lasts. 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