{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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"drugstartdateformat": "102", "drugstartdate": "20181023", "drugenddateformat": "102", "drugenddate": "20190409", "actiondrug": "6", "activesubstance": { "activesubstancename": "METOCLOPRAMIDE" }, "openfda": { "application_number": [ "ANDA073135", "ANDA073118", "ANDA204756", "ANDA078807", "ANDA091392", "ANDA070184", "ANDA072801", "ANDA071402", "ANDA072744", "ANDA072215", "NDA017854" ], "brand_name": [ "METOCLOPRAMIDE" ], "generic_name": [ "METOCLOPRAMIDE", "METOCLOPRAMIDE HYDROCHLORIDE" ], "manufacturer_name": [ "Teva Parenteral Medicines, Inc.", "Hospira, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Ipca Laboratories Limited", "Avenacy Inc.", "Fresenius Kabi USA, LLC", "Teva Pharmaceuticals USA, Inc.", "ANI Pharmaceuticals, Inc.", "Genus Lifesciences Inc.", "ScieGen Pharmaceuticals, Inc.", "PAI Holdings, LLC dba PAI Pharma" ], "product_ndc": [ "0703-4502", "0409-3414", "23155-240", "83980-010", "83980-011", "83634-779", "0409-5255", "76045-101", 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"76045-213-00", "76045-213-20", "0093-2204-01", "0093-2204-05", "0093-2203-01", "0093-2203-05", "0093-2203-10", "0703-4502-91", "0703-4502-93", "62559-190-16", "64950-344-16", "50228-232-01", "50228-232-05", "50228-233-01", "50228-233-05", "50228-233-10", "62559-295-01", "62559-296-01", "0121-0576-16", "0121-1576-10" ], "unii": [ "W1792A2RVD" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "048", "drugindication": "HYPERTENSION", "drugstartdateformat": "102", "drugstartdate": "20181025", "actiondrug": "6", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20190320" } } } ] }