{ "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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"drugcharacterization": "2", "medicinalproduct": "IBUPROFEN", "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA074916", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA071333", "NDA020603", "ANDA076460", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", "ANDA071334", "ANDA209178", "ANDA071935", "M013", "ANDA079058", "ANDA072199", "NDA020812", "ANDA071265", "ANDA090796", "ANDA071335", "ANDA211666", "ANDA215777", 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"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": "MULTIVITAMINS", "actiondrug": "4", "activesubstance": { "activesubstancename": "VITAMINS" } }, { "drugcharacterization": "2", "medicinalproduct": "VALTREX", "drugdosagetext": "UNK UNK, AS NEEDED (PRN)", "drugindication": "ORAL HERPES", "actiondrug": "4", "activesubstance": { 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"drugdosagetext": "EXPIRY DATE: MAR-2015", "drugadministrationroute": "058", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20121219", "drugenddateformat": "102", "drugenddate": "20140518", "actiondrug": "1", "activesubstance": { "activesubstancename": "CERTOLIZUMAB PEGOL" } }, { "drugcharacterization": "2", "medicinalproduct": "NEXIUM", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, ONCE DAILY (QD)", "drugadministrationroute": "048", "drugindication": "PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER", "actiondrug": "4", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022101", "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": "CALCIUM", "actiondrug": "4", "activesubstance": { "activesubstancename": "CALCIUM" }, "openfda": { "brand_name": [ "7030 CALCIUM PREMIUM", "AG-X", "7030 CALCIUM GOLD" ], "generic_name": [ "CALCIUM" ], "manufacturer_name": [ "Apexel Co., Ltd", "APEXEL CO., LTD." ], "product_ndc": [ "55259-1112", "55259-0007", "55259-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CALCIUM" ], "spl_id": [ "0fa8135f-89c9-41a2-e063-6294a90a403d", "11cc283a-fe2c-f101-e063-6294a90ad2d4", "11cc310a-d82e-be44-e063-6394a90a227c" ], "spl_set_id": [ "bdc7c833-daf7-48f9-e053-2995a90ad88e", "bdee5e24-645b-7fa0-e053-2995a90a7d25", "bdc7c088-83e3-20ce-e053-2995a90abd2f" ], "package_ndc": [ "55259-1112-1", "55259-0007-1", "55259-0001-1" ], "nui": [ "M0003153", "N0000175901" ], "pharm_class_cs": [ "Calcium [CS]" ], "pharm_class_epc": [ "Calcium [EPC]" ], "unii": [ "SY7Q814VUP" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CRANBERRY.", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "UNK UNK, 2X/DAY (BID)", "drugdosageform": "TABLET", "actiondrug": "4", "activesubstance": { "activesubstancename": "CRANBERRY" } }, { "drugcharacterization": "1", "medicinalproduct": "CERTOLIZUMAB PEGOL RA", "drugauthorizationnumb": "125160", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugdosagetext": "Q2 WEEKS X3", "drugadministrationroute": "058", "drugstartdateformat": "102", "drugstartdate": "20121107", "drugenddateformat": "102", "drugenddate": "20121205", "actiondrug": "1", "activesubstance": { "activesubstancename": "CERTOLIZUMAB PEGOL" } }, { "drugcharacterization": "2", "medicinalproduct": "SYNTHROID", "drugstructuredosagenumb": ".125", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": ".125 MG, ONCE DAILY (QD)", "drugadministrationroute": "048", "drugindication": "HYPOTHYROIDISM", "actiondrug": "4", "activesubstance": { "activesubstancename": "LEVOTHYROXINE SODIUM" }, "openfda": { "application_number": [ "NDA021402" ], "brand_name": [ "SYNTHROID" ], "generic_name": [ "LEVOTHYROXINE SODIUM" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-3727", "0074-4341", "0074-4552", "0074-5182", "0074-6594", "0074-6624", "0074-9296", "0074-7068", "0074-7069", "0074-7070", "0074-7148", "0074-7149" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEVOTHYROXINE SODIUM" ], "rxcui": [ "892246", "892251", "892255", "966158", "966171", "966185", "966191", "966201", "966205", "966218", "966220", "966221", "966222", "966224", "966225", "966247", "966248", "966249", "966250", "966251", "966253", "966270", "966271", "966282" ], "spl_id": [ "b85ab7fa-ba96-43cd-b736-44b3924e644c" ], "spl_set_id": [ "1e11ad30-1041-4520-10b0-8f9d30d30fcc" ], "package_ndc": [ "0074-4341-13", "0074-4341-90", "0074-4341-19", "0074-4341-72", "0074-4552-13", "0074-4552-90", "0074-4552-19", "0074-4552-11", "0074-4552-71", "0074-4552-72", "0074-5182-13", "0074-5182-90", "0074-5182-71", "0074-5182-19", "0074-5182-11", "0074-5182-72", "0074-6594-13", "0074-6594-90", "0074-6594-71", "0074-6594-19", "0074-6594-72", "0074-6624-13", "0074-6624-90", "0074-6624-19", "0074-6624-11", "0074-6624-71", "0074-6624-72", "0074-9296-13", "0074-9296-90", "0074-9296-19", "0074-9296-71", "0074-9296-72", "0074-7068-13", "0074-7068-90", "0074-7068-71", "0074-7068-19", "0074-7068-11", "0074-7068-72", "0074-3727-13", "0074-3727-90", "0074-3727-71", "0074-3727-19", "0074-3727-72", "0074-7069-90", "0074-7069-71", "0074-7069-19", "0074-7069-11", "0074-7069-72", "0074-7070-13", "0074-7070-90", "0074-7070-71", "0074-7070-19", "0074-7070-72", "0074-7148-90", "0074-7148-19", "0074-7148-71", "0074-7148-11", "0074-7148-72", "0074-7149-90", "0074-7149-19" ], "unii": [ "9J765S329G" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201311" } } }, { "safetyreportversion": "1", "safetyreportid": "10006330", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "2", "companynumb": "US-BAYER-2014-037686", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "US-BAYER-2014-037686" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "45", "patientonsetageunit": "801", "patientweight": "89.8", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Deep vein thrombosis", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "YAZ", "drugauthorizationnumb": "021676", "drugdosageform": "FILM-COATED TABLET", "openfda": { "application_number": [ "NDA021676" ], "brand_name": [ "YAZ" ], "generic_name": [ "DROSPIRENONE AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-405" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "630734", "748797", "748798", "748856" ], "spl_id": [ "4f14f9c9-411b-48b0-a3d3-cac639cdfb8b" ], "spl_set_id": [ "065f33e4-b587-4e66-b896-ca9ab7b7c876" ], "package_ndc": [ "50419-405-03" ] } }, { "drugcharacterization": "1", "medicinalproduct": "YASMIN", "drugdosageform": "FILM-COATED TABLET", "openfda": { "application_number": [ "NDA021098" ], "brand_name": [ "YASMIN" ], "generic_name": [ "DROSPIRENONE AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-402" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "284207", "748797", "748800", "748857" ], "spl_id": [ "84c4a6e5-8157-4f6d-a51f-3665e8568a3c" ], "spl_set_id": [ "d7ea6a60-5a56-4f81-b206-9b27b7e58875" ], "package_ndc": [ "50419-402-03" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SINGULAIR", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, UNK", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20081013", "openfda": { "application_number": [ "NDA020830", "NDA021409", "NDA020829" ], "brand_name": [ "SINGULAIR" ], "generic_name": [ "MONTELUKAST SODIUM" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-170", "78206-171", "78206-173", "78206-172" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MONTELUKAST SODIUM" ], "rxcui": [ "153892", "153893", "200224", "242438", "261367", "311759", "351246", "404406" ], "spl_id": [ 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"73469-2053", "59390-149" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "TOPICAL", "TRANSDERMAL", "OPHTHALMIC" ], "substance_name": [ "DICLOFENAC SODIUM", "DICLOFENAC" ], "rxcui": [ "1487074", "857700", "2705052", "2705057", "855633", "854801" ], "spl_id": [ "1affc043-5b84-4b94-97be-90f3bd954f34", "28dafbef-5a91-4435-b48d-00137ea268b5", "6feda2fe-70b6-4dbe-a969-97857501dd1f", "463f4bb7-e16f-4966-e063-6294a90a58eb", "a723bc13-8e04-48e5-8427-5cb5e6471e4a", "3f399f7d-a801-4fce-9c3a-7e3a4d6e2507", "0561ff06-43b4-493e-93f7-b778fc829036" ], "spl_set_id": [ "45321aec-368d-4ca4-a0c5-2ce56fae74b2", "e7304b3e-530a-4519-aed0-bed4512d8925", "78873f83-cea9-44d4-8ad4-8cb9257e5c7f", "2d93a01c-40a9-8fb0-e063-6394a90a2cc6", "1084e0c3-6d75-4090-84dc-02a18e0299b9", "8dcbce69-945b-4913-a279-ee10871f6580", "5372866a-dab3-45c8-8c2a-755ca36c1791" ], "package_ndc": [ "65162-683-12", "21922-033-16", "65162-911-74", "83295-5500-1", "69238-2053-1", "73469-2053-1", "73469-2053-8", "59390-149-02", "59390-149-05" ], "unii": [ "QTG126297Q", "144O8QL0L1" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IBUPROFEN", "drugstructuredosagenumb": "800", "drugstructuredosageunit": "003", "drugdosagetext": "800 MG, UNK", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20090103", "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", 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