{"id":"pyridoxine","rwe":[],"_fda":{"id":"973ff5d8-ba4b-4641-a3a0-3840e4630ce3","set_id":"038fe2e7-dc16-485c-b5fb-746db7231347","openfda":{"nui":["N0000193618","M0001797","M0003153","N0000175901","M0022797","N0000175952","M0022794","N0000175951","N0000192800","N0000005657","N0000175452"],"unii":["WR1WPI7EW8","PQ6CK8PD0R","SY7Q814VUP","1C6V77QF41","P6YC3EG204","ZAD9OKH9JC","R5L488RY0Q","935E97BOY8","I38ZP9992A","KV2JZ1BI6Z"],"route":["ORAL"],"spl_id":["973ff5d8-ba4b-4641-a3a0-3840e4630ce3"],"brand_name":["PNV-DHA"],"spl_set_id":["038fe2e7-dc16-485c-b5fb-746db7231347"],"package_ndc":["42192-321-30"],"product_ndc":["42192-321"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Ascorbic Acid [CS]","Calcium [CS]","Vitamin D [CS]","Vitamin B 12 [CS]","Vitamin B 6 [Chemical/Ingredient]","Analogs/Derivatives [Chemical/Ingredient]"],"substance_name":[".ALPHA.-TOCOPHEROL ACETATE, DL-","ASCORBIC ACID","CALCIUM","CHOLECALCIFEROL","CYANOCOBALAMIN","DOCONEXENT","FERROUS FUMARATE","FOLIC ACID","MAGNESIUM","PYRIDOXINE"],"pharm_class_epc":["Vitamin C [EPC]","Calcium [EPC]","Vitamin D [EPC]","Vitamin B12 [EPC]","Vitamin B6 Analog [EPC]"],"manufacturer_name":["Acella Pharmaceuticals, LLC"],"is_original_packager":[true]},"version":"3","warnings":["WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding."],"description":["DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side. Supplement Facts Serving Size 1 Tablet Amount Per Serving % DV %DV for Pregnant or Lactating Women Vitamin C 85 mg 142% 142% Vitamin D 3 200 IU 50% 50% Vitamin E 10 IU 33% 33% Vitamin D 6 25 mg 1250% 1000% Folate 1 mg 250% 125% (L-methylfolate calcium 676 mcg (as Xolafin-B™ Percent Daily Values are based on a 2000 calorie diet ) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) Vitamin B 12 12 mcg 200% 150% Calcium 140 mg 14% 11% Iron (ferrous fumarate) 27 mg 150% 150% Magnesium 45 mg 11% 10% Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mg Daily Value (DV) not established OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3. INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"precautions":["PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"how_supplied":["HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30). Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"boxed_warning":["WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"effective_time":"20240115","adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description_table":["
Supplement Facts
Serving Size 1 Tablet
Amount Per Serving % DV %DV for Pregnant or Lactating Women
Vitamin C85 mg142%142%
Vitamin D 3200 IU50%50%
Vitamin E10 IU33%33%
Vitamin D 625 mg1250%1000%
Folate1 mg250%125%
(L-methylfolate calcium 676 mcg (as Xolafin-B™ Percent Daily Values are based on a 2000 calorie diet) molar equivalent to 600 mcg of Folic Acid)
(folic acid, USP 400 mcg)
Vitamin B 1212 mcg200%150%
Calcium140 mg14%11%
Iron (ferrous fumarate)27 mg150%150%
Magnesium45 mg11%10%
Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mgDaily Value (DV) not established
"],"inactive_ingredient":["OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3."],"indications_and_usage":["INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation."],"spl_unclassified_section":["Rx Only","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.","All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.","MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 04/10v6 *Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"spl_product_data_elements":["PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent CARNAUBA WAX CORN OIL LECITHIN, SOYBEAN GELATIN GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM FERROUS FUMARATE FERROUS CATION MAGNESIUM MAGNESIUM DOCONEXENT DOCONEXENT BP;321"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-321-30 PNV-DHA Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets"]},"tags":[{"label":"Vitamin B6 Analog","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Cystathionine beta-synthase","category":"target"},{"label":"CBS","category":"gene"},{"label":"PSAT1","category":"gene"},{"label":"PDXK","category":"gene"},{"label":"A11HA02","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":"Breastfeeding (mother)","category":"indication"},{"label":"Drug-Induced Pyridoxine Deficiency","category":"indication"},{"label":"Pregnancy, function","category":"indication"},{"label":"Pyridoxine-Dependent Seizure","category":"indication"},{"label":"Vitamin B6 deficiency","category":"indication"},{"label":"Hospira","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Micronutrients","category":"pharmacology"},{"label":"Vitamin B Complex","category":"pharmacology"},{"label":"Vitamins","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"533 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"470 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"456 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"408 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"357 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"343 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"334 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"332 reports"},{"date":"","signal":"SOMNOLENCE","source":"FDA FAERS","actionTaken":"309 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"308 reports"}],"commonSideEffects":[{"effect":"Paresthesia","drugRate":"reported","severity":"unknown"},{"effect":"Somnolence","drugRate":"reported","severity":"unknown"},{"effect":"Low serum folic acid levels","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute hepatic failure","Acute hepatitis","Acute nephropathy","Alcoholism","Anemia due to enzyme deficiency","Atrophic gastritis","Autoimmune disease","Chronic Hepatic Disease","Chronic heart failure","Dehydration","Depressive disorder","Diabetes mellitus","Diabetic - poor control","Diabetic peripheral neuropathy","Diarrhea","Disease of liver","Diverticular disease","Esophageal Compression","Esophageal dysmotility","Gastrectomy","Gastroenteritis","Gastrointestinal hemorrhage","Gastrointestinal obstruction","Gastroparesis","Genitourinary Tract Infections"],"specialPopulations":{"Pregnancy":"The requirement for pyridoxine appears to be increased during pregnancy. Pyridoxine is sometimes of value in the treatment of nausea and vomiting of pregnancy.","Paediatric use":"Safety and effectiveness in children have not been established."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PYRIDOXINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:40:16.368669+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:40:22.442813+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:40:15.496762+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PYRIDOXINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:40:22.999788+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:40:13.440383+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:40:13.440406+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:40:13.440412+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:40:24.655539+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1364/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:40:23.724937+00:00"}},"allNames":"pyridoxine hydrochloride","offLabel":[],"synonyms":["pyridoxine","adermin","bezatin","pirivitol","pyridoxin","pyridoxine hydrochloride","pyridoxine (vit B6)","vitamin b6","pyridoxine HCl"],"timeline":[{"date":"1993-12-29","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"}],"aiSummary":"Pyridoxine Hydrochloride is a small molecule with the synonyms including Pyridoxine. It is used in various clinical trials, including those for conditions such as fibroids, stroke, and stress, often in combination with other interventions like dydrogesterone or folic acid.","approvals":[{"date":"1993-12-29","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Pyridoxine Hydrochloride","ecosystem":[{"indication":"Breastfeeding (mother)","otherDrugs":[{"name":"ascorbic acid","slug":"ascorbic-acid","company":""},{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""}],"globalPrevalence":null},{"indication":"Drug-Induced Pyridoxine Deficiency","otherDrugs":[],"globalPrevalence":null},{"indication":"Pregnancy, function","otherDrugs":[{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"eicosapentaenoic acid","slug":"eicosapentaenoic-acid","company":""}],"globalPrevalence":null},{"indication":"Pyridoxine-Dependent Seizure","otherDrugs":[],"globalPrevalence":null},{"indication":"Vitamin B6 deficiency","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Cystathionine beta-synthase","novelty":"Follow-on","targets":[{"gene":"CBS","source":"DrugCentral","target":"Cystathionine beta-synthase","protein":"Cystathionine beta-synthase"},{"gene":"PSAT1","source":"DrugCentral","target":"Phosphoserine aminotransferase","protein":"Phosphoserine aminotransferase"},{"gene":"PDXK","source":"DrugCentral","target":"Pyridoxal kinase","protein":"Pyridoxal kinase"},{"gene":"PDXP","source":"DrugCentral","target":"Pyridoxal phosphate phosphatase","protein":"Pyridoxal phosphate phosphatase"},{"gene":"PNPO","source":"DrugCentral","target":"Pyridoxine-5'-phosphate oxidase","protein":"Pyridoxine-5'-phosphate oxidase"},{"gene":"SHMT1","source":"DrugCentral","target":"Serine hydroxymethyltransferase, cytosolic","protein":"Serine hydroxymethyltransferase, cytosolic"}],"modality":"Small Molecule","drugClass":"Vitamin C [EPC]","explanation":"","oneSentence":"","technicalDetail":"Pyridoxine Hydrochloride acts as a coenzyme for cystathionine beta-synthase, a crucial enzyme in the transsulfuration pathway, facilitating the conversion of homocysteine to cystathionine and ultimately contributing to the regulation of homocysteine levels in the body."},"commercial":{"launchDate":"1993","_launchSource":"DrugCentral (FDA 1993-12-29, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2836","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PYRIDOXINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PYRIDOXINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:28:40.302151","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:40:26.935313+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"nicotinamide","drugSlug":"nicotinamide","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"Vitamin E","drugSlug":"vitamin-e","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"riboflavin","drugSlug":"riboflavin","fdaApproval":"1953-02-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"biotin","drugSlug":"biotin","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"pyridoxal phosphate","drugSlug":"pyridoxal-phosphate","fdaApproval":"","relationship":"same-class"},{"drugName":"inositol","drugSlug":"inositol","fdaApproval":"","relationship":"same-class"},{"drugName":"tocofersolan","drugSlug":"tocofersolan","fdaApproval":"","relationship":"same-class"},{"drugName":"dexpanthenol","drugSlug":"dexpanthenol","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"calcium pantothenate","drugSlug":"calcium-pantothenate","fdaApproval":"1993-12-29","relationship":"same-class"},{"drugName":"pantethine","drugSlug":"pantethine","fdaApproval":"","relationship":"same-class"}],"genericName":"pyridoxine","indications":{"approved":[{"name":"Breastfeeding (mother)","source":"DrugCentral","snomedId":413712001,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Drug-Induced Pyridoxine Deficiency","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Patients taking isoniazid (INH) or oral contraceptives"},{"name":"Pregnancy, function","source":"DrugCentral","snomedId":289908002,"regulator":"FDA"},{"name":"Pyridoxine-Dependent Seizure","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Patients with vitamin B6 dependent convulsions"},{"name":"Vitamin B6 deficiency","source":"DrugCentral","snomedId":386080007,"regulator":"FDA","eligibility":"Patients with inadequate dietary intake, inborn errors of metabolism, anorexia, nausea and vomiting, preoperative and postoperative conditions, or impaired gastrointestinal absorption"}],"offLabel":[],"pipeline":[]},"drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"nicotinamide","brandName":"nicotinamide","genericName":"nicotinamide","approvalYear":"1953","relationship":"same-class"},{"drugId":"vitamin-e","brandName":"Vitamin E","genericName":"Vitamin E","approvalYear":"1953","relationship":"same-class"},{"drugId":"riboflavin","brandName":"riboflavin","genericName":"riboflavin","approvalYear":"1953","relationship":"same-class"},{"drugId":"biotin","brandName":"biotin","genericName":"biotin","approvalYear":"1953","relationship":"same-class"},{"drugId":"pyridoxal-phosphate","brandName":"pyridoxal phosphate","genericName":"pyridoxal 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Hershey Medical Center","startDate":"2027-12","conditions":["Ischemia Reperfusion Injury","Peripheral Artery Disease"],"enrollment":30,"completionDate":"2028-09"},{"nctId":"NCT06234501","phase":"NA","title":"Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism","status":"RECRUITING","sponsor":"University of Reading","startDate":"2024-11-08","conditions":["Autism"],"enrollment":40,"completionDate":"2026-07"},{"nctId":"NCT06415383","phase":"PHASE1","title":"The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance","status":"COMPLETED","sponsor":"University of Reading","startDate":"2024-05-30","conditions":["Pain"],"enrollment":43,"completionDate":"2025-06-30"},{"nctId":"NCT06654089","phase":"PHASE4","title":"A Study Evaluating Quality of Life Parameters Following Use of Emergen-C","status":"COMPLETED","sponsor":"HALEON","startDate":"2024-10-30","conditions":["Dietary 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Trial","status":"COMPLETED","sponsor":"University Tunis El Manar","startDate":"2024-07-01","conditions":["System; Lupus Erythematosus"],"enrollment":59,"completionDate":"2025-05-07"},{"nctId":"NCT01391962","phase":"PHASE2","title":"Sunitinib or Cediranib for Alveolar Soft Part Sarcoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2011-07-18","conditions":["Sarcoma, Alveolar Soft Part"],"enrollment":34,"completionDate":"2026-01-16"},{"nctId":"NCT07380438","phase":"NA","title":"A Clinical Study to Evaluate the Efficacy of a Nutritional Supplement to Improve Carotenoid Content as Measured by a Non-invasive Hyperspectral Absorption Device","status":"COMPLETED","sponsor":"Pharmanex","startDate":"2025-10-20","conditions":["Nutrition Assessment"],"enrollment":84,"completionDate":"2026-01-08"},{"nctId":"NCT07363148","phase":"NA","title":"A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese 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