{ "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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"activesubstancename": "FUROSEMIDE" }, "openfda": { "application_number": [ "NDA016273" ], "brand_name": [ "LASIX" ], "generic_name": [ "FUROSEMIDE" ], "manufacturer_name": [ "Validus Pharmaceuticals LLC" ], "product_ndc": [ "30698-060", "30698-067", "30698-066" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FUROSEMIDE" ], "rxcui": [ "197732", "200801", "200809", "205732", "310429", "313988" ], "spl_id": [ "4002943d-0b4b-4ff0-e063-6394a90ae63b" ], "spl_set_id": [ "2c9b4d8f-0770-482d-a9e6-9c616a440b1a" ], "package_ndc": [ "30698-067-01", "30698-067-10", "30698-060-01", "30698-060-10", "30698-060-50", "30698-066-05", "30698-066-50" ], "nui": [ "N0000175366", "N0000175590" ], "pharm_class_pe": [ "Increased Diuresis at Loop of Henle [PE]" ], "pharm_class_epc": [ "Loop Diuretic [EPC]" ], "unii": [ "7LXU5N7ZO5" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140226" } } }, { "safetyreportversion": "1", "safetyreportid": 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"NDA021957", "NDA021153" ], "brand_name": [ "NEXIUM" ], "generic_name": [ "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-4010", "0186-5020", "0186-4020", "0186-4040", "0186-5040", "0186-4025", "0186-4050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE" ], "rxcui": [ "606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763" ], "spl_id": [ "26f66e74-b652-4b1d-bfff-62a3cc87d590" ], "spl_set_id": [ "f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RANITIDINE", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "RANITIDINE\\RANITIDINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA078192", "ANDA075294", "ANDA209859", "ANDA077824", "ANDA210243", "ANDA211289", "ANDA077405" ], "brand_name": [ "RANITIDINE", "RANITIDINE COOL MINT" ], "generic_name": [ "RANITIDINE" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Limited", "Ajanta Pharma USA Inc.", "Amneal Pharmaceuticals of New York LLC", "Granules India Ltd", "Rising Pharma Holdings, Inc.", "Pharmaceutical Associates, Inc." ], "product_ndc": [ "55111-404", "55111-131", "27241-109", "27241-110", "53746-253", "53746-254", "62207-773", "62207-774", "64980-636", "64980-637", "0121-0727", "0121-4727" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RANITIDINE HYDROCHLORIDE", "RANITIDINE" ], "rxcui": [ "198191", "312773", "198190", 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"brand_name": [ "JAKAFI" ], "generic_name": [ "RUXOLITINIB" ], "manufacturer_name": [ "Incyte Corporation" ], "product_ndc": [ "50881-005", "50881-010", "50881-015", "50881-020", "50881-025", "50881-011", "50881-022", "50881-033", "50881-044", "50881-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RUXOLITINIB" ], "rxcui": [ "1193331", "1193337", "1193339", "1193341", "1193343", "1193345", "1193347", "1193349", "1193351", "1193353", "2743012", "2743016", "2743019", "2743022", "2743025", "2743028", "2743032", "2743035", "2743041", "2743044" ], "spl_id": [ "1c261eb0-f426-47a1-8281-62282d207644" ], "spl_set_id": [ "f1c82580-87ae-11e0-bc84-0002a5d5c51b" ], "package_ndc": [ "50881-005-60", "50881-010-01", "50881-010-60", "50881-015-60", "50881-020-60", "50881-025-60", "50881-011-08", "50881-022-08", "50881-033-08", "50881-044-08", "50881-055-08" ], "nui": [ "N0000175605", "N0000190858", "N0000190857" ], "pharm_class_epc": [ "Kinase Inhibitor 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