{ "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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"rxcui": [ "597768", "597770", "597772", "616159", "616161", "616163" ], "spl_id": [ "17c39217-5502-420d-8d2e-799626756189" ], "spl_set_id": [ "3495a70c-870c-4968-940e-8baea152cf85" ], "package_ndc": [ "0078-0468-15", "0078-0469-15", "0078-0470-15" ], "nui": [ "N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138" ], "pharm_class_moa": [ "Iron Chelating Activity [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]" ], "pharm_class_epc": [ "Iron Chelator [EPC]" ], "unii": [ "V8G4MOF2V9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NORVASC", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA019787" ], "brand_name": [ "NORVASC" ], "generic_name": [ "AMLODIPINE BESYLATE" ], "manufacturer_name": [ "Viatris Specialty LLC", "PFIZER LABORATORIES DIV PFIZER INC" ], "product_ndc": [ "58151-353", "58151-354", "58151-355", "0069-1520", "0069-1530", "0069-1540" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE" ], "rxcui": [ "197361", "212542", "212549", "212575", "308135", "308136" ], "spl_id": [ "643fa1a0-53d9-4ce8-bc04-44285b006997", "3714a872-b6c6-4d74-88d2-add8a895e311" ], "spl_set_id": [ "7367289c-b0b0-466a-83e2-558e2985c29f", "abd6a2ca-40c2-485c-bc53-db1c652505ed" ], "package_ndc": [ "58151-353-77", "58151-354-77", "58151-354-88", "58151-354-30", "58151-355-77", "58151-355-88", "0069-1520-68", "0069-1530-68", "0069-1530-41", "0069-1530-72", "0069-1540-68", "0069-1540-41" ], "unii": [ "864V2Q084H" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140110" } } }, { "safetyreportversion": "2", "safetyreportid": "10003608", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": 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Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "AMERISOURCE BERGEN", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rite Aid Corporation", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. 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"drugintervaldosagedefinition": "804", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "CALCIUM CARBONATE- VITAMIN D", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "TABLET", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" } ] } } ] }