{"id":"ammonia","rwe":[],"_fda":{"id":"bf01478c-3377-4b2c-905c-30807e865825","set_id":"26572b37-0999-4c83-8206-1c088026d407","openfda":{"nui":["N0000177914","N0000000205"],"unii":["9OQO0E343Z"],"route":["INTRAVENOUS"],"spl_id":["bf01478c-3377-4b2c-905c-30807e865825"],"brand_name":["Ammonia N 13"],"spl_set_id":["26572b37-0999-4c83-8206-1c088026d407"],"package_ndc":["62072-456-56"],"product_ndc":["62072-456"],"generic_name":["AMMONIA N-13"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["AMMONIA N-13"],"pharm_class_epc":["Radioactive Diagnostic Agent [EPC]"],"pharm_class_moa":["Radiopharmaceutical Activity [MoA]"],"manufacturer_name":["Kreitchman PET Center"],"application_number":["ANDA203938"],"is_original_packager":[true]},"version":"7","effective_time":"20260127","adverse_reactions":["6 ADVERSE REACTIONS No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system (6) . To report SUSPECTED ADVERSE REACTIONS, contact Kreitchman PET Center at 212-305-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"spl_unclassified_section":["Manufactured by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032 Distributed by: Kreitchman PET Center, 722 W 168th Street, R-1 Level Room 110, New York, NY 10032"],"spl_product_data_elements":["Ammonia N 13 AMMONIA N-13 AMMONIA N-13 AMMONIA N-13"],"package_label_principal_display_panel":["product label"]},"tags":[{"label":"ammonia","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V09GX05","category":"atc"},{"label":"Respiratory (Inhalation)","category":"route"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Inhalant","category":"form"},{"label":"Liniment","category":"form"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Active","category":"status"},{"label":"Acne vulgaris","category":"indication"},{"label":"Disorder of keratinization","category":"indication"},{"label":"Pityriasis simplex","category":"indication"},{"label":"Psoriasis","category":"indication"},{"label":"Seborrheic dermatitis","category":"indication"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"SEIZURE","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"MIGRAINE","source":"FDA FAERS","actionTaken":"10 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"8 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"DEPRESSION","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"DRUG ABUSE","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"GASTRIC DISORDER","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"7 reports"}],"commonSideEffects":[],"contraindications":["Blister","Condyloma acuminatum","Diabetes mellitus","Infection of skin AND/OR subcutaneous tissue","Inflammatory dermatosis","Peripheral vascular disease","Skin irritation"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ammonia","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:47:20.593373+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ammonia","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:47:28.903764+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:47:27.527028+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:47:19.236823+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ammonia","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:47:28.315349+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":"2026-04-20T00:47:18.203672+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:18.203737+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:18.203752+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":"2026-04-20T00:47:29.811816+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1160819/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:47:28.787726+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA203938","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:18.203760+00:00"}},"allNames":["ammonia"],"offLabel":[],"synonyms":["ammonia"],"timeline":[{"date":"2015-04-22","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 16 manufacturers approved"}],"ecosystem":[{"indication":"Acne vulgaris","otherDrugs":[{"name":"adapalene","slug":"adapalene","company":"Galderma Labs Lp"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"azelaic acid","slug":"azelaic-acid","company":"Allergan"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Disorder of keratinization","otherDrugs":[{"name":"benzoin","slug":"benzoin","company":""}],"globalPrevalence":null},{"indication":"Pityriasis simplex","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"carbamide","slug":"carbamide","company":"Hospira"},{"name":"chloroxine","slug":"chloroxine","company":""},{"name":"ciclopirox","slug":"ciclopirox","company":"Medimetriks Pharms"}],"globalPrevalence":null},{"indication":"Psoriasis","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""}],"globalPrevalence":125000000},{"indication":"Seborrheic dermatitis","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"allantoin","slug":"allantoin","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"Radioactive Diagnostic Agent [EPC]","explanation":"","oneSentence":"","technicalDetail":"Ammonia's exact mechanism of action is not fully understood, but it is believed to involve the alteration of the skin's pH through the release of ammonia ions, which can help to reduce the growth of certain bacteria and other microorganisms that contribute to skin conditions."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ammonia","title":"Ammonia","extract":"Ammonia is an inorganic chemical compound of nitrogen and hydrogen with the formula NH3. A stable binary hydride and the simplest pnictogen hydride, ammonia is a colourless gas with a distinctive pungent smell. It is widely used in fertilizers, refrigerants, explosives, cleaning agents, and is a precursor for numerous chemicals. Biologically, it is a common nitrogenous waste, and it contributes significantly to the nutritional needs of terrestrial organisms by serving as a precursor to fertilisers. Around 70% of ammonia produced industrially is used to make fertilisers in various forms and composition, such as urea and diammonium phosphate. Ammonia in pure form is also applied directly into the soil."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4625","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ammonia","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ammonia","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Ammonia","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":"2026-03-30T08:42:35.038379","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:47:31.528487+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"rubidium Rb-82 chloride","drugSlug":"rubidium-rb-82-chloride","fdaApproval":"1989-12-29","relationship":"same-class"}],"genericName":"ammonia","indications":{"approved":[{"name":"Acne vulgaris","source":"DrugCentral","snomedId":88616000,"regulator":"FDA","eligibility":"Not specified in the given text"},{"name":"Disorder of keratinization","source":"DrugCentral","snomedId":277905003,"regulator":"FDA","eligibility":"Not specified in the given text"},{"name":"Pityriasis simplex","source":"DrugCentral","snomedId":200767005,"regulator":"FDA","eligibility":"Not specified in the given text"},{"name":"Psoriasis","source":"DrugCentral","snomedId":9014002,"regulator":"FDA","eligibility":"Not specified in the given text","usPrevalence":7500000,"globalPrevalence":125000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Seborrheic dermatitis","source":"DrugCentral","snomedId":50563003,"regulator":"FDA","eligibility":"Not specified in the given text"}],"offLabel":[],"pipeline":[]},"currentOwner":"Feinstein","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"rubidium-rb-82-chloride","brandName":"rubidium Rb-82 chloride","genericName":"rubidium Rb-82 chloride","approvalYear":"1989","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03648905","phase":"","title":"Clinical Laboratory Evaluation of Chronic Autonomic Failure","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","startDate":"2018-09-06","conditions":["Parkinson's Disease","Multiple System Atrophy","Autonomic Failure"],"enrollment":89,"completionDate":"2029-12-31"},{"nctId":"NCT03275584","phase":"PHASE4","title":"Safety of PET MPI Using the CRCHUM N-13 Ammonia","status":"RECRUITING","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","startDate":"2018-01-30","conditions":["N-13 Ammonia Safety"],"enrollment":20000,"completionDate":"2028-01"},{"nctId":"NCT04941248","phase":"","title":"Total-body 13N-NH3 PET/CT to Study the Blood Perfusion in Severe AS Patients Pre- and Post-TAVR in Whole Body","status":"COMPLETED","sponsor":"RenJi Hospital","startDate":"2021-06-27","conditions":["Cardiac Output"],"enrollment":34,"completionDate":"2026-02-08"},{"nctId":"NCT07454408","phase":"PHASE1,PHASE2","title":"Evaluation of the Outcome of Fecal Microbiota Transplantation","status":"NOT_YET_RECRUITING","sponsor":"Air Force Military Medical University, China","startDate":"2026-03-07","conditions":["Hepatic Encephalopathy","Fecal Microbiota Transplantation","TIPS"],"enrollment":40,"completionDate":"2028-06-30"},{"nctId":"NCT07224035","phase":"PHASE4","title":"Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Miami","startDate":"2022-10-15","conditions":["H Pylori Infection","H Pylori Gastritis","Gastric Cancer"],"enrollment":500,"completionDate":"2027-11-06"},{"nctId":"NCT07224048","phase":"PHASE4","title":"Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Miami","startDate":"2024-11-06","conditions":["H. 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