{ "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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"medicinalproduct": "CONCERTA", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "METHYLPHENIDATE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA021121" ], "brand_name": [ "CONCERTA" ], "generic_name": [ "METHYLPHENIDATE HYDROCHLORIDE" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-585", "50458-588", "50458-586", "50458-587" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METHYLPHENIDATE HYDROCHLORIDE" ], "rxcui": [ "1091155", "1091157", "1091170", "1091172", "1091185", "1091187", "1091210", "1091212" ], "spl_id": [ "64d7c1e1-e7ed-4d74-a44d-13b4da64af9a" ], "spl_set_id": [ "1a88218c-5b18-4220-8f56-526de1a276cd" ], "package_ndc": [ "50458-585-01", "50458-588-01", "50458-586-01", "50458-587-01" ], "unii": [ "4B3SC438HI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "VITAMIN D NOS" }, "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: 201903" } } } ] }