{ "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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"62756-240-83", "62756-356-64", "62756-356-83", "62756-356-66" ], "unii": [ "NMH84OZK2B", "4AF302ESOS" ], "nui": [ "N0000175817", "N0000175818" ], "pharm_class_moa": [ "Serotonin 3 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Serotonin-3 Receptor Antagonist [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RANITIDINE.", "activesubstance": { "activesubstancename": "RANITIDINE" }, "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", "198192", "198193", "705610" ], "spl_id": [ "c47f1d10-c4d9-5df4-84e8-55956b47568b", "210e3c0b-be93-aa50-550d-e383e7d5f19e", "d7fd99da-f17a-4124-9014-70bbe43d78f6", "906b462d-e4a3-4f23-8d1b-2605476c40e8", "44f2b222-ae43-eef4-e063-6394a90ab2b6", "b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe", "d56a22ea-5dab-e98a-e053-2a95a90a34c4" ], "spl_set_id": [ "00df8a42-296f-80dd-98af-ee8b30eb38cc", "12a38e29-130c-6d41-1753-acccb0b41efe", "fb67e8c7-b817-4253-a1a1-5ecdcee694cf", "b38a3332-5c54-453f-aeb7-070f830955c2", "aab81d9f-397d-49fb-8083-77a1872cc71f", "0fba6615-37c2-4ba6-b6e5-09599369a5bc", "d0da9dd6-c691-4614-99c7-531b0bf34837" ], "package_ndc": [ "55111-404-34", "55111-404-32", "55111-404-36", "55111-404-50", "55111-404-61", "55111-404-55", "55111-404-62", "55111-404-90", "55111-404-02", "55111-404-65", "55111-404-17", "55111-404-24", "55111-404-38", "55111-404-40", "55111-131-30", "55111-131-60", "55111-131-80", "55111-131-90", "55111-131-04", "55111-131-37", "55111-131-79", "55111-131-14", "55111-131-81", "55111-131-45", "27241-109-06", "27241-109-50", "27241-110-03", "27241-110-10", "53746-253-60", "53746-253-01", "53746-253-18", "53746-253-05", "53746-253-10", "53746-254-30", "53746-254-01", "53746-254-02", "62207-774-58", "62207-774-41", "62207-774-47", "62207-774-36", "62207-773-58", "62207-773-41", "62207-773-47", "62207-773-32", "62207-773-36", "64980-636-03", "64980-637-03", "0121-0727-16", "0121-4727-10" ], "unii": [ "BK76465IHM", "884KT10YB7" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20170723" } } } ] }