{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "6", "safetyreportid": "13004128", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20191004", "reporttype": "2", "serious": "2", "receivedateformat": "102", "receivedate": "20161206", "receiptdateformat": "102", "receiptdate": "20190809", "fulfillexpeditecriteria": "2", "companynumb": "US-JAZZ-2016-US-022169", "duplicate": "1", "reportduplicate": { "duplicatesource": "JAZZ", "duplicatenumb": "US-JAZZ-2016-US-022169" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": 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"a3745850-3e32-4884-b315-161bcb9996ed" ], "package_ndc": [ "0280-0115-02", "0280-0115-01", "0280-0115-03", "0280-0130-02", "0280-0130-01", "0280-0114-01", "0280-0114-02", "0280-0114-03", "0280-0114-04", "0280-0114-05", "0280-0114-08", "0280-6020-20", "0280-6020-40", "0280-6020-80", "0280-6020-16", "0280-6020-02", "0280-0111-01", "0280-0111-02", "0280-0111-03", "0280-0111-04", "0280-0111-05", "0280-0111-06", "0280-0111-07", "0280-6050-50", "0280-6050-01", "0280-6050-27", "0280-6050-02", "0280-6050-03", "0280-6050-04", "0280-6050-06", "0280-6050-05", "0280-6070-40", "0280-0112-01", "0280-0112-02", "0280-0112-03", "0280-0112-04", "0280-6010-24", "0280-6010-50", "0280-6010-01", "0280-6010-02", "0280-6010-03", "0280-6010-04", "0280-6010-06", "0280-6010-05", "0280-6010-07", "0280-6010-09", "0280-6010-10", "0280-0113-01", "0280-0113-02", "0280-0113-03", "0280-0113-04", "0280-0113-05", "0280-0113-06", "0280-0131-01", "66715-6402-8", "66715-9702-1", "66715-9702-2", "66715-9702-3", "66715-9702-0", "66715-6502-2", "66715-6411-2", "0280-8252-24", "0280-8252-10", "0280-6080-20", "0280-6080-40", "0280-6080-80", "0280-6080-16", "0280-6080-01", "0280-6080-02", "0280-6080-03", "0280-6080-04", "66715-5103-0", "0280-6091-80", "0280-6060-20", "0280-6060-25", "0280-6060-32", "0280-6000-06", "0280-6000-24", "0280-6000-50", "0280-6000-10", "0280-6000-15", "0280-6000-02", "0280-6000-27", "0280-6000-32", "0280-6000-70", "0280-6000-75", "0280-6000-01", "0280-6000-03", "0280-6000-04", "0280-6000-05", "0280-6000-07", "0280-6000-08", "0280-6000-12", "0280-6000-09", "0280-6000-16" ], "unii": [ "9TN87S3A3C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XANAX", "drugdosagetext": "UNK", "drugdosageform": "TABLET", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20140101", "drugenddateformat": "102", "drugenddate": "20150903", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "openfda": { "application_number": [ "NDA018276", "NDA021434" ], "brand_name": [ "XANAX", "XANAX XR" ], "generic_name": [ "ALPRAZOLAM" ], "manufacturer_name": [ "PHARMACIA & UPJOHN COMPANY LLC", "Viatris Specialty LLC" ], "product_ndc": [ "0009-0029", "0009-0055", "0009-0090", "0009-0094", "58151-505", "58151-503", "58151-504", "58151-506", "58151-452", "58151-453", "58151-454", "58151-455" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ALPRAZOLAM" ], "rxcui": [ "141927", "141928", "197321", "197322", "214003", "214004", "308047", "308048", "433798", "433799", "433800", "433801", "687022", "687023", "687024", "687025" ], "spl_id": [ "f5323eac-81d0-4096-ac15-2f25220c5c28", "7ceb0a8d-f766-4806-a289-652080edf4a3", "27062ff4-9ce3-4d8a-aeae-f4468efb623a" ], "spl_set_id": [ "388e249d-b9b6-44c3-9f8f-880eced0239f", "c8990714-c2f5-4b0c-9f1c-91d77156d962", "bb5cf72e-3a41-41a8-9a38-80f974eca33f" ], "package_ndc": [ "0009-0029-01", "0009-0029-46", "0009-0029-02", "0009-0029-14", "0009-0055-01", "0009-0055-46", "0009-0055-03", "0009-0055-15", "0009-0090-01", "0009-0090-04", "0009-0090-13", "0009-0094-01", "0009-0094-03", "58151-503-91", "58151-504-91", "58151-505-91", "58151-506-91", "58151-452-01", "58151-452-05", "58151-453-01", "58151-453-05", "58151-454-01", "58151-454-05", "58151-455-01" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "YU55MQ3IZY" ] } } ] } } ] }