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"activesubstancename": "FLUOROURACIL" }, "openfda": { "application_number": [ "NDA020985", "ANDA202668", "ANDA217676", "ANDA040278", "ANDA210124", "ANDA217295", "NDA016831", "ANDA210123", "ANDA215612", "ANDA076526", "ANDA203609", "ANDA040743", "ANDA040798", "NDA022259", "ANDA090368", "ANDA077524", "ANDA214845", "NDA220201", "ANDA216494", "ANDA040279", "ANDA216942", "ANDA215699", "ANDA202669" ], "brand_name": [ "FLUOROURACIL", "TOLAK", "EFUDEX", "FAVLYXA" ], "generic_name": [ "FLUOROURACIL CREAM, 0.5%", "FLUOROURACIL" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Inc.", "Eugia US LLC", "Alembic Pharmaceuticals Inc.", "Fresenius Kabi USA, LLC", "BluePoint Laboratories", "Mylan Pharmaceuticals Inc.", "Gland Pharma Limited", "Encube Ethicals, Inc.", "Sun Pharmaceutical Industries, Inc.", "Sagent Pharmaceuticals", "Accord Healthcare, Inc.", "Xiromed LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Alembic Pharmaceuticals Limited", "HILL DERMACEUTICALS, INC.", 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"a0cd6301-c6e0-4b62-8683-39c99913db24", "c45f5286-a52b-43e5-8a6f-d0312e7da0c8", "30294dd2-40fb-420d-b838-376343308895", "a85ab26a-05ea-498f-8f34-564a925fa9d9", "de8a3fce-85a9-4a77-a3cd-e50179b93098", "697816ce-dc05-4943-b7f0-2f0b125e93b7", "ea3497db-23b9-4ace-9a6f-b54853d04a82", "fdf2a165-2ca4-48be-89c1-570e6010b47c", "52ef5f41-2312-4b55-aa86-abd5bb28b9d3" ], "package_ndc": [ "75907-169-11", "55150-496-01", "55150-496-10", "55150-497-01", "55150-497-10", "62332-779-31", "63323-117-58", "63323-117-68", "63323-117-51", "63323-117-61", "68001-525-27", "68001-525-32", "62332-751-50", "0378-4791-06", "68083-269-01", "68083-269-10", "68083-270-01", "68083-270-10", "21922-041-12", "51672-4062-1", "51672-4063-1", "25021-215-98", "25021-215-99", "16729-276-03", "16729-276-68", "16729-276-05", "16729-276-67", "70700-188-22", "70700-189-22", "23155-972-31", "23155-972-41", "23155-973-31", "23155-973-41", "70700-187-22", "70700-187-23", "70700-186-22", "70700-186-23", "16729-276-11", "16729-276-38", "46708-779-31", "28105-421-40", "51672-4118-5", "51672-4118-2", "51672-4118-6", "23155-974-31", "23155-975-31", "68001-524-28", "68001-524-30", "68001-524-29", "68001-524-31", "63323-117-59", "63323-117-69", "75907-095-40", "68001-628-32", "16729-542-35", "0187-3202-10", "0187-3202-02", "0187-3203-10", "0187-3203-02", "0187-3204-47", "83831-143-01", "83831-164-10", "51862-362-40", "46708-751-50", "68001-627-27", "71288-170-75", "63323-117-00", "63323-117-10", "63323-117-01", "63323-117-20", "21922-049-17", "63323-117-43", "63323-117-18", "63323-117-41", "63323-117-28", "71288-154-76", "55150-498-01", "55150-499-01", "68083-292-01", "68083-293-01", "63323-117-31", "63323-117-19", "16714-178-01" ], "nui": [ "N0000000233", "N0000175595" ], "pharm_class_moa": [ "Nucleic Acid Synthesis Inhibitors [MoA]" ], "pharm_class_epc": [ "Nucleoside Metabolic Inhibitor [EPC]" ], "unii": [ "U3P01618RT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D3", "drugstructuredosagenumb": "2000", "drugstructuredosageunit": "025", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "TABLETS", "drugadministrationroute": "048", "drugindication": "VITAMIN SUPPLEMENTATION", "drugstartdateformat": "602", "drugstartdate": "2015", "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" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TIAZAC", "drugstructuredosagenumb": "120", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "CAPSULES", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "610", "drugstartdate": "202009", "activesubstance": { "activesubstancename": "DILTIAZEM HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA020401" ], "brand_name": [ "TIAZAC EXTENDED RELEASE" ], "generic_name": [ "DILTIAZEM HYDROCHLORIDE" ], "manufacturer_name": [ "Bausch Health US, LLC" ], "product_ndc": [ "0187-2612", "0187-2613", "0187-2614", "0187-2615", "0187-2616", "0187-2617" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DILTIAZEM HYDROCHLORIDE" ], "rxcui": [ "830795", "830801", "830837", "830845", "830861", "831193", "831244", "831296", "831323", "831347", "831359", "831360" ], "spl_id": [ "d16e7ace-3d95-4196-a7b0-cdd26f3bd8e7" ], "spl_set_id": [ "c567fe7e-887e-4291-a0d1-2dd3f25cbf25" ], "package_ndc": [ "0187-2612-30", "0187-2612-90", "0187-2613-30", "0187-2613-90", "0187-2614-30", "0187-2614-90", "0187-2615-30", "0187-2615-90", "0187-2616-30", "0187-2616-90", "0187-2617-30", "0187-2617-90" ], "unii": [ "OLH94387TE" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XALATAN", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "BEFORE GOING TO SLEEP AT NIGHT", "drugdosageform": "SOLUTION", "drugadministrationroute": "047", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "602", "drugstartdate": "2015", "activesubstance": { "activesubstancename": "LATANOPROST" }, "openfda": { "application_number": [ "NDA020597" ], "brand_name": [ "XALATAN" ], "generic_name": [ "LATANOPROST" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-419" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "OPHTHALMIC" ], "substance_name": [ "LATANOPROST" ], "rxcui": [ "314072", "542527" ], "spl_id": [ "45489b8b-2aab-4336-8552-1524493289f9" ], "spl_set_id": [ "a98595b3-9f47-48e0-b18d-550a2095f264" ], "package_ndc": [ "58151-419-35" ], "nui": [ "N0000175454", "M0017805" ], "pharm_class_epc": [ "Prostaglandin Analog [EPC]" ], "pharm_class_cs": [ "Prostaglandins [CS]" ], "unii": [ "6Z5B6HVF6O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "EMLA", "drugdosagetext": "CREAM; AS NECESSITATE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PROCEDURAL PAIN", "drugstartdateformat": "610", "drugstartdate": "202007", "activesubstance": { "activesubstancename": "LIDOCAINE\\PRILOCAINE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 202006" } } } ] }