{ "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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"50580-198-52", "50580-198-05", "50580-563-20", "50580-563-40", "50580-563-80" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "WK2XYI10QM", "4OD433S209" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HYDRODIURIL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "HYDROCHLOROTHIAZIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "ADVIL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "IBUPROFEN" }, "openfda": { "application_number": [ "NDA201803", "NDA018989", "NDA020402" ], "brand_name": [ "ADVIL" ], "generic_name": [ "IBUPROFEN SODIUM", "IBUPROFEN", "IBUPROFEN TABLETS, COATED" ], "manufacturer_name": [ "Haleon US Holdings LLC", "Lil' Drug Store Products, Inc." ], "product_ndc": [ "0573-0133", "0573-0134", "0573-0150", "0573-0165", "0573-0154", "0573-0151", "0573-0161", "0573-0166", "0573-0160", "0573-1711", "0573-0149", "0573-0169", "0573-1769", "66715-6434", "66715-9700", "66715-6500", "66715-5803" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN SODIUM", "IBUPROFEN" ], "rxcui": [ "153008", "310965", "310964", "731533" ], "spl_id": [ "40429ef4-846a-eb4c-e063-6394a90ab7a9", "4cd840a6-9554-de58-e063-6394a90ab543", "57c53bdc-fb89-a4d9-e063-6294a90a1bfb", "2cb6ac3b-ffe3-21bc-e063-6394a90a4569", "1d786176-599d-19ad-e063-6294a90a9237" ], "spl_set_id": [ "5be198b8-396e-4b44-8819-e2e3b5d2ad0e", "1a665e64-9f30-be37-4a83-38789f1f1e89", "1f01c10a-9434-91a4-2ee4-352315a6b610", "772360bd-8631-4d24-b4db-5a7e6e1d9a13", "dd302e18-39e9-7e1a-e053-2a95a90a5f7c" ], "package_ndc": [ "0573-0133-20", "0573-0133-40", "0573-0133-80", "0573-0133-02", "0573-0133-04", "0573-0133-89", "0573-0133-81", "0573-0133-05", "0573-0133-88", "0573-0133-41", "0573-0133-91", "0573-0133-01", "0573-0134-20", "0573-0134-80", "0573-0165-20", "0573-0165-30", "0573-0165-40", "0573-0165-41", "0573-0165-42", "0573-0165-31", "0573-0165-25", "0573-0154-35", "0573-0154-75", "0573-0154-17", "0573-0154-89", "0573-0154-84", "0573-0154-98", "0573-0154-16", "0573-0154-60", "0573-0154-59", "0573-0154-21", "0573-0151-12", "0573-0151-13", "0573-0151-10", "0573-0151-21", "0573-0151-20", "0573-0151-48", "0573-0151-30", "0573-0151-05", "0573-0151-40", "0573-0161-35", "0573-0161-51", "0573-0161-85", "0573-0161-65", "0573-0166-51", "0573-0166-85", "0573-0150-20", "0573-0150-30", "0573-0150-40", "0573-0150-31", "0573-0150-32", "0573-0150-41", "0573-0150-42", "0573-0160-20", "0573-0160-30", "0573-0160-40", "0573-0160-25", "0573-0160-31", "0573-0160-41", "0573-0160-42", "0573-0160-17", "0573-1711-14", "0573-0169-17", "0573-0169-02", "0573-0169-19", "0573-0169-20", "0573-0169-40", "0573-0169-11", "0573-0169-89", "0573-0169-30", "0573-0169-31", "0573-0169-86", "0573-0169-51", "0573-0169-43", "0573-0169-49", "0573-0169-52", "0573-0169-08", "0573-0169-22", "0573-0169-13", "0573-0169-76", "0573-0169-16", "0573-0149-13", "0573-0149-04", "0573-0149-66", "0573-0149-91", "0573-1769-20", "0573-1769-80", "0573-1769-89", "0573-1769-14", "0573-1769-13", "0573-1769-09", "0573-1769-02", "0573-1769-87", "0573-1769-16", "0573-1769-31", "0573-1769-92", "66715-9700-1", "66715-9700-2", "66715-9700-3", "66715-9700-8", "66715-9700-7", "66715-6500-2", "66715-6434-2", "66715-5803-0" ], "unii": [ "RM1CE97Z4N", "WK2XYI10QM" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D3", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "CHOLECALCIFEROL" }, "openfda": { "application_number": [ "ANDA090455" ], "brand_name": [ "VITAMIN D" ], "generic_name": [ "ERGOCALCIFEROL" ], "manufacturer_name": [ "Strides Pharma Science Limited" ], "product_ndc": [ "64380-737" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ERGOCALCIFEROL" ], "rxcui": [ "1367410" ], "spl_id": [ "1cc589f7-cd6d-40a6-8fce-c965e8945eae" ], "spl_set_id": [ "2c4c0a36-12cf-444d-9d57-de983eef4d36" ], "package_ndc": [ "64380-737-06", "64380-737-25" ], "nui": [ "M0007651", "N0000175909" ], "pharm_class_cs": [ "Ergocalciferols [CS]" ], "pharm_class_epc": [ "Provitamin D2 Compound [EPC]" ], "unii": [ "VS041H42XC" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20221205" } } } ] }