{ "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": "1", "safetyreportid": "18290427", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20201103", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20200921", "receiptdateformat": "102", "receiptdate": "20200921", "fulfillexpeditecriteria": "2", "companynumb": "US-GW PHARMA-202009USGW03109", "duplicate": "1", "reportduplicate": { "duplicatesource": "GW PHARMA", "duplicatenumb": "US-GW PHARMA-202009USGW03109" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": 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USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DIVALPROEX SODIUM" }, "openfda": { "application_number": [ "NDA021168", "NDA018723", "NDA019680" ], "brand_name": [ "DEPAKOTE ER", "DEPAKOTE", "DEPAKOTE SPRINKLES" ], "generic_name": [ "DIVALPROEX SODIUM" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-7401", "0074-3826", "0074-7126", "0074-7402", "0074-7325", "0074-6212", "0074-6214", "0074-6215", "0074-7327", "0074-7326", "0074-6114" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIVALPROEX SODIUM" ], "rxcui": [ "1099563", "1099565", "1099569", "1099571", "1099625", "1099626", "1099678", "1099679", "1099870", "1099871", "1099596", "1099598" ], "spl_id": [ "0ee65b66-ead3-44ef-911f-14965b067903", "7cc3a0b3-93f8-4825-88e1-bf6ddb0db23d", "d038b7e9-b014-4771-93be-90aeeaece03d" ], "spl_set_id": [ "0dc024ce-efc8-4690-7cb5-639c728fccac", "08a65cf4-7749-4ceb-6895-8f4805e2b01f", "4619aff4-0f80-444f-858d-42e4137aa809" ], "package_ndc": [ "0074-3826-13", "0074-3826-11", "0074-7401-13", "0074-7126-13", "0074-7126-53", "0074-7126-11", "0074-7126-72", "0074-7402-13", "0074-6212-13", "0074-6214-13", "0074-6214-53", "0074-6215-13", "0074-6215-53", "0074-7325-13", "0074-7327-13", "0074-7326-13", "0074-6114-13", "0074-6114-11" ], "unii": [ "644VL95AO6" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LAMICTAL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "LAMOTRIGINE" }, "openfda": { "application_number": [ "NDA020764", "NDA020241", "NDA022251", "NDA022115" ], "brand_name": [ "LAMICTAL", "LAMICTAL ODT", "LAMICTAL XR" ], "generic_name": [ "LAMOTRIGINE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0526", "0173-0633", "0173-0642", "0173-0643", "0173-0644", "0173-0699", "0173-0527", "0173-0772", "0173-0774", "0173-0776", "0173-0777", "0173-0594", "0173-0779", "0173-0780", "0173-0778", "0173-0817", "0173-0754", "0173-0755", "0173-0756", "0173-0757", "0173-0758", "0173-0760", "0173-0759", "0173-0761", "0173-0781" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LAMOTRIGINE" ], "rxcui": [ "103968", "105018", "105019", "108782", "198427", "198428", "198429", "198430", "201239", "201240", "206201", "252478", "252479", "282401", "311264", "311265", "349010", "542426", "751139", "751563", "753451", "795772", "795774", "795778", "849049", "849050", "849051", "849052", "851748", "851749", "851750", "851751", "851752", "851753", "850087", "850091", "900145", "900156", "900157", "900164", "900165", "900169", "900865", "900866", "900890", "900891", "900983", "900984", "1098608", "1098610", "1146690", "1146692" ], "spl_id": [ "076c76e0-4a5e-491b-ba85-de2dd757b436", "d0cca76f-809f-4db8-a468-619a217debc1" ], "spl_set_id": [ "d7e3572d-56fe-4727-2bb4-013ccca22678", "3e2c9a35-6a39-41d7-ad84-3c0bb8894b09" ], "package_ndc": [ "0173-0633-02", "0173-0633-10", "0173-0642-55", "0173-0643-60", "0173-0644-60", "0173-0699-02", "0173-0699-00", "0173-0526-00", "0173-0527-00", "0173-0772-02", "0173-0774-02", "0173-0776-02", "0173-0777-02", "0173-0594-02", "0173-0779-00", "0173-0780-00", "0173-0778-00", "0173-0817-28", "0173-0754-00", "0173-0755-00", "0173-0756-00", "0173-0757-00", "0173-0758-00", "0173-0760-00", "0173-0759-00", "0173-0761-00", "0173-0781-00" ], "nui": [ "N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191" ], "pharm_class_epc": [ "Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_moa": [ "Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]" ], "unii": [ "U3H27498KS" ] } }, { "drugcharacterization": "1", "medicinalproduct": "EPIDIOLEX", "drugbatchnumb": "W003442", "drugstructuredosagenumb": "310", "drugstructuredosageunit": "003", "drugdosagetext": "310 MILLIGRAM, BID", "drugdosageform": "ORAL SOLUTION", "drugadministrationroute": "048", "drugindication": "LENNOX-GASTAUT SYNDROME", "drugstartdateformat": "102", "drugstartdate": "20191203", "actiondrug": "4", "activesubstance": { "activesubstancename": "CANNABIDIOL" }, "openfda": { "application_number": [ "NDA210365" ], "brand_name": [ "EPIDIOLEX" ], "generic_name": [ "CANNABIDIOL" ], "manufacturer_name": [ "Jazz Pharmaceuticals, Inc." ], "product_ndc": [ "70127-100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CANNABIDIOL" ], "rxcui": [ "2058900", "2058906" ], "spl_id": [ "1eb7ac65-8df5-4a4a-9156-802cfaa92b06" ], "spl_set_id": [ "8bf27097-4870-43fb-94f0-f3d0871d1eec" ], "package_ndc": [ "70127-100-01", "70127-100-10", "70127-100-06", "70127-100-60" ], "nui": [ "M0003267", "N0000187062", "N0000185504", "N0000182140", "N0000191278", "N0000191273", "N0000182138", "N0000182139", "N0000187064" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]" ], "unii": [ "19GBJ60SN5" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 202008" } } } ] }