{ "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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"unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FENOTEROL\\IPRATROPIUM BROMIDE", "drugdosagetext": "DOSE: 2 DOSES DAILY.", "drugstartdateformat": "602", "drugstartdate": "2006", "activesubstance": { "activesubstancename": "FENOTEROL\\IPRATROPIUM BROMIDE" } }, { "drugcharacterization": "1", "medicinalproduct": "AMLODIPINE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "602", "drugstartdate": "2006", "actiondrug": "4", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA214439", "NDA211340" ], "brand_name": [ "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "46287-035-15", "46287-037-01", "52652-5001-1" ], "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]" ], "unii": [ "1J444QC288", "XD75TQ8A2P" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ENALAPRIL", "drugdosageform": "UNASSIGNED", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "602", "drugstartdate": "2006", "actiondrug": "4", "activesubstance": { "activesubstancename": "ENALAPRIL" }, "openfda": { "application_number": [ "ANDA212894" ], "brand_name": [ "ENALAPRIL MALEATE" ], "generic_name": [ "ENALAPRIL" ], "manufacturer_name": [ "Amneal Pharmaceuticals NY LLC" ], "product_ndc": [ "69238-1729" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ENALAPRIL MALEATE" ], "rxcui": [ "1435624" ], "spl_id": [ "4f8091c3-1233-48b9-a15e-e5da07c4272c" ], "spl_set_id": [ "e81a8aca-0e7c-4a02-b596-09e4ac22c70e" ], "package_ndc": [ "69238-1729-7" ], "unii": [ "9O25354EPJ" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20090917" } } } ] }