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], "route": [ "ORAL" ], "substance_name": [ "FLUOXETINE HYDROCHLORIDE" ], "rxcui": [ "104849", "205535", "261287", "310384", "310385", "313989" ], "spl_id": [ "e49a90e3-e7da-4377-8736-ebe9f53c3097" ], "spl_set_id": [ "c88f33ed-6dfb-4c5e-bc01-d8e36dd97299" ], "package_ndc": [ "0777-3104-02", "0777-3105-02", "0777-3105-30", "0777-3107-30" ], "unii": [ "I9W7N6B1KJ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PAXIL", "activesubstance": { "activesubstancename": "PAROXETINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA020936", "NDA020031" ], "brand_name": [ "PAXIL CR", "PAXIL" ], "generic_name": [ "PAROXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Apotex Corp" ], "product_ndc": [ "60505-4377", "60505-4378", "60505-4379", "60505-3668", "60505-3669", "60505-3670", "60505-4517", "60505-4518", "60505-4519", "60505-4520" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PAROXETINE HYDROCHLORIDE" ], "rxcui": [ "1738803", "1738804", "1738805", "1738806", "1738807", "1738808", "207349", "207350", "211699", "211700", "1738483", "1738495", "1738503", "1738511" ], "spl_id": [ "57998b73-87c9-7fed-ffa8-7e43620bd98a", "62b4ffe1-48e2-6dd5-d7ca-28e8efe36686" ], "spl_set_id": [ "483bd97f-c4d0-4e23-aaa8-6334f4471e0c", "ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e" ], "package_ndc": [ "60505-4377-3", "60505-4378-3", "60505-4379-3", "60505-3668-3", "60505-3669-3", "60505-3670-3", "60505-4517-3", "60505-4518-3", "60505-4519-3", "60505-4520-3" ], "unii": [ "X2ELS050D8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEXAPRO", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "4", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, QID", "drugadministrationroute": "048", "drugindication": "DEPRESSION", "drugstartdateformat": "602", "drugstartdate": "2005", "activesubstance": { "activesubstancename": "ESCITALOPRAM OXALATE" }, 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"drugcharacterization": "1", "medicinalproduct": "MIRENA", "drugbatchnumb": "3530B", "drugauthorizationnumb": "021225", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "004", "drugdosagetext": "20 MCG/24HR, CONT", "drugdosageform": "INTRAUTERINE DELIVERY SYSTEM", "drugadministrationroute": "015", "drugindication": "CONTRACEPTION", "drugstartdateformat": "102", "drugstartdate": "20040823", "drugenddateformat": "102", "drugenddate": "20070404", "actiondrug": "1", "activesubstance": { "activesubstancename": "LEVONORGESTREL" }, "openfda": { "application_number": [ "NDA021225" ], "brand_name": [ "MIRENA" ], "generic_name": [ "LEVONORGESTREL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-423" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAUTERINE" ], "substance_name": [ "LEVONORGESTREL" ], "rxcui": [ "804156", "807283" ], "spl_id": [ "ab3e1924-b102-48c1-8188-a089524e9dd0" ], "spl_set_id": [ "dcbd6aa2-b3fa-479a-a676-56ea742962fc" ], "package_ndc": [ "50419-423-01", "50419-423-08" ], "nui": [ "N0000175830", "M0447349", "N0000175602", "N0000175832" ], "pharm_class_pe": [ "Inhibit Ovum Fertilization [PE]" ], "pharm_class_cs": [ "Progesterone Congeners [CS]" ], "pharm_class_epc": [ "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]" ], "unii": [ "5W7SIA7YZW" ] } }, { "drugcharacterization": "2", "medicinalproduct": "KEFLEX", "activesubstance": { "activesubstancename": "CEPHALEXIN" } }, { "drugcharacterization": "2", "medicinalproduct": "LIBRAX", "activesubstance": { "activesubstancename": "CHLORDIAZEPOXIDE HYDROCHLORIDE\\CLIDINIUM BROMIDE" }, "openfda": { "application_number": [ "NDA012750" ], "brand_name": [ "LIBRAX" ], "generic_name": [ "CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE" ], "manufacturer_name": [ "Bausch Health US, LLC" ], "product_ndc": [ "0187-4100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CHLORDIAZEPOXIDE HYDROCHLORIDE", "CLIDINIUM BROMIDE" ], "rxcui": [ "889614", "889616" ], "spl_id": [ "98fd8b52-2fc3-4540-8333-75b5c853aee2" ], "spl_set_id": [ "f99ebf66-f207-4a97-9666-4da1d72b061c" ], "package_ndc": [ "0187-4100-10" ], "unii": [ "MFM6K1XWDK", "91ZQW5JF1Z" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2004" } } }, { "safetyreportversion": "2", "safetyreportid": "10006611", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140602", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014068220", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014068220" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": 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