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"drugadministrationroute": "048", "drugstartdateformat": "610", "drugstartdate": "202101", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "openfda": { "application_number": [ "NDA204026" ], "brand_name": [ "POMALYST" ], "generic_name": [ "POMALIDOMIDE" ], "manufacturer_name": [ "Celgene Corporation" ], "product_ndc": [ "59572-501", "59572-502", "59572-503", "59572-504" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POMALIDOMIDE" ], "rxcui": [ "1369718", "1369724", "1369726", "1369728", "1369730", "1369732", "1369734", "1369736" ], "spl_id": [ "4410582a-a5f3-429f-a7ca-5c17fb5560bf" ], "spl_set_id": [ "2b25ef01-5c9e-11e1-b86c-0800200c9a66" ], "package_ndc": [ "59572-501-21", "59572-501-00", "59572-502-21", "59572-502-00", "59572-503-21", "59572-503-00", "59572-504-21", "59572-504-00" ], "nui": [ "N0000184014" ], "pharm_class_epc": [ "Thalidomide Analog [EPC]" ], "unii": [ "D2UX06XLB5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMITRIPTYLINE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMITRIPTYLINE" } }, { "drugcharacterization": "1", "medicinalproduct": "POMALYST", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 MILLIGRAM", "drugdosageform": "CAPSULES", "drugadministrationroute": "048", "drugstartdateformat": "610", "drugstartdate": "202003", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "openfda": { "application_number": [ "NDA204026" ], "brand_name": [ "POMALYST" ], "generic_name": [ "POMALIDOMIDE" ], "manufacturer_name": [ "Celgene Corporation" ], "product_ndc": [ "59572-501", "59572-502", "59572-503", "59572-504" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POMALIDOMIDE" ], "rxcui": [ "1369718", "1369724", "1369726", "1369728", "1369730", "1369732", "1369734", "1369736" ], "spl_id": [ "4410582a-a5f3-429f-a7ca-5c17fb5560bf" ], "spl_set_id": [ "2b25ef01-5c9e-11e1-b86c-0800200c9a66" ], "package_ndc": [ "59572-501-21", "59572-501-00", "59572-502-21", "59572-502-00", "59572-503-21", "59572-503-00", "59572-504-21", "59572-504-00" ], "nui": [ "N0000184014" ], "pharm_class_epc": [ "Thalidomide Analog [EPC]" ], "unii": [ "D2UX06XLB5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LUNESTA", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ESZOPICLONE" }, "openfda": { "application_number": [ "NDA021476" ], "brand_name": [ "LUNESTA" ], "generic_name": [ "ESZOPICLONE" ], "manufacturer_name": [ "Waylis Therapeutics LLC" ], "product_ndc": [ "80725-010", "80725-011", "80725-012" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESZOPICLONE" ], "rxcui": [ "485440", "485442", "485465", "540407", "540409", "540411" ], "spl_id": [ "4a1b20fc-a41d-41dd-a557-fa9333bb5c3b" ], "spl_set_id": [ "3821f4b7-a3c8-4920-ba80-18aa96532c09" ], "package_ndc": [ "80725-010-30", "80725-011-30", "80725-012-30" ], "unii": [ "UZX80K71OE" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MARINOL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DRONABINOL" }, "openfda": { "application_number": [ "NDA018651" ], "brand_name": [ "MARINOL" ], "generic_name": [ "DRONABINOL" ], "manufacturer_name": [ "ThePharmaNetwork, LLC" ], "product_ndc": [ "53097-568", "53097-569", "53097-570", "53097-571", "53097-572", "53097-573" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DRONABINOL" ], "rxcui": [ "197634", "197635", "197636", "205641", "205642", "205645" ], "spl_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48" ], "spl_set_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "d0efeeec-640d-43c3-8f0a-d31324a11c68" ], "package_ndc": [ "53097-568-60", "53097-569-60", "53097-570-60", "53097-571-60", "53097-572-60", "53097-573-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 202107" } } } ] }