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INDICA TOP" } }, { "drugcharacterization": "2", "medicinalproduct": "TEMAZEPAM.", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "TEMAZEPAM" }, "openfda": { "application_number": [ "ANDA203482", "ANDA071620", "ANDA211542", "ANDA071456", "ANDA071457", "ANDA201781", "NDA018163" ], "brand_name": [ "TEMAZEPAM", "RESTORIL" ], "generic_name": [ "TEMAZEPAM" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Actavis Pharma, Inc.", "Alembic Pharmaceuticals Limited", "Ascend Laboratories, LLC", "Alembic Pharmaceuticals Inc.", "Solco Healthcare U.S., LLC", "SpecGx LLC", "Amneal Pharmaceuticals of New York LLC" ], "product_ndc": [ "65162-556", "65162-583", "65162-584", "65162-557", "0228-2076", "0228-2077", "46708-379", "46708-380", "46708-381", "46708-382", "67877-146", "67877-148", "67877-149", "67877-147", "62332-379", "62332-380", "62332-381", "62332-382", "43547-611", "43547-612", "43547-613", "43547-614", "0406-9914", "0406-9915", "0406-9916", "0406-9917", "0406-9959", "0406-9960", "0406-9961", "0406-9962", "53746-556", "53746-557" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "TEMAZEPAM" ], "rxcui": [ "198241", "198242", "198243", "485489", "208463", "208464", "208465", "539384" ], "spl_id": [ "20d2675f-af6d-480c-9152-6f722fb1ea22", "3050ee1e-c494-48ce-be40-6424e9661d87", "387adad5-eb5e-429f-bc8a-b9ace387bc3f", "220f0470-b5b1-4ce4-bae5-bd761a245dd4", "f6347a33-09dd-4938-92eb-4bcc48a31cfa", "5f04458d-b81c-47f8-ab06-3c47dffc5e4d", "f0ee4fa9-cdff-4111-83a5-0885c81de4e4", "973fc0b9-31b8-4958-9cb6-bd1ae12538e9", "18d70b19-ff94-443e-8169-cb7e87895146" ], "spl_set_id": [ "be68c6e0-17ad-40fe-9bc1-58abe24b53f6", "a4370eb4-b00d-4247-af8d-980e59fbbec6", "db839409-8e95-41d3-804e-dcd5d11f4934", "8f54731f-c5b7-492c-acb0-444c5fbb7029", "93b1be7f-ec41-46bb-a258-56cb459e2c92", "3ce42f0e-821e-4c9a-8f6b-60621628fd4b", "bc56f7fd-1aaf-48ff-8aa7-d467e59e1015", "c9bc61b4-a579-4003-98da-b6f6e381c150", "6248295e-8176-48f8-8e9d-bba6deacaf0d" ], "package_ndc": [ "65162-583-03", "65162-583-10", "65162-583-50", "65162-583-11", "65162-556-03", "65162-556-10", "65162-556-50", "65162-556-11", "65162-584-03", "65162-584-10", "65162-584-50", "65162-584-11", "65162-557-03", "65162-557-10", "65162-557-50", "65162-557-11", "0228-2076-10", "0228-2076-50", "0228-2077-10", "0228-2077-50", "46708-379-30", "46708-379-31", "46708-380-30", "46708-380-90", "46708-380-31", "46708-380-71", "46708-381-30", "46708-382-30", "46708-382-90", "46708-382-31", "46708-382-71", "67877-148-30", "67877-148-01", "67877-148-05", "67877-146-01", "67877-146-05", "67877-149-30", "67877-149-01", "67877-149-05", "67877-147-01", "67877-147-05", "62332-379-30", "62332-379-31", "62332-380-30", "62332-380-90", "62332-380-31", "62332-380-71", "62332-381-30", "62332-382-30", "62332-382-90", "62332-382-31", "62332-382-71", "43547-611-10", "43547-612-10", "43547-612-50", "43547-613-03", "43547-614-10", "43547-614-50", "0406-9915-03", "0406-9915-01", "0406-9916-01", "0406-9914-03", "0406-9917-01", "0406-9960-01", "0406-9959-03", "0406-9961-01", "0406-9962-01", "53746-556-01", "53746-556-05", "53746-557-01", "53746-557-05" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "CHB1QD2QSS" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20131008" } } } ] }