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"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" } } }, { "safetyreportversion": "3", "safetyreportid": "10020874", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "3", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140319", "receiptdateformat": "102", "receiptdate": "20140417", "fulfillexpeditecriteria": "1", "companynumb": "JP-NAPPMUNDI-GBR-2014-0017472", "duplicate": "1", "reportduplicate": { "duplicatesource": "PURDUE", "duplicatenumb": "JP-NAPPMUNDI-GBR-2014-0017472" }, "primarysource": { "reportercountry": "JP", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "61", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Oesophageal rupture", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vomiting", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OXYCODONE HCL PR TABLET 10 MG", "drugauthorizationnumb": "022272", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, UNK", "drugdosageform": "PROLONGED-RELEASE TABLET", "drugadministrationroute": "065", "drugindication": "ANALGESIC THERAPY", "actiondrug": "1", "drugrecurreadministration": "3" }, { "drugcharacterization": "1", "medicinalproduct": "OXYCODONE HCL IR POWDER 0.5%", "drugdosageform": "POWDER FOR ORAL SOLUTION", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3" }, { "drugcharacterization": "1", "medicinalproduct": "OXYCODONE HYDROCHLORIDE", "drugdosageform": "Other", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA207418", "ANDA204752", "NDA022272", "ANDA203638", "ANDA204021", "ANDA209897", "ANDA202773", "ANDA204979", "NDA021011", "NDA209777", "ANDA091490", "ANDA202662", "ANDA205177", "ANDA210758", "ANDA206914", "ANDA213761", "ANDA202160", "ANDA077712", "NDA200535", "ANDA208593", "ANDA204037", "ANDA207511", 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