{ "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": "2", "safetyreportid": "17500984", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20200409", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20200305", "receiptdateformat": "102", "receiptdate": "20200310", "fulfillexpeditecriteria": "1", "companynumb": "US-GW PHARMA-202002USGW00706", "duplicate": "1", "reportduplicate": { "duplicatesource": "GW PHARMA", "duplicatenumb": "US-GW PHARMA-202002USGW00706" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, 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"73581-913-40" ], "nui": [ "N0000010288", "N0000175811", "N0000009871" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P", "FVS1AZD90Y", "B697894SGQ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DIASTAT ACUDIAL", "drugstructuredosagenumb": "12.5", "drugstructuredosageunit": "003", "drugdosagetext": "12.5 MILLIGRAM, PRN", "drugadministrationroute": "054", "drugindication": "SEIZURE", "activesubstance": { "activesubstancename": "DIAZEPAM" } }, { "drugcharacterization": "2", "medicinalproduct": "ZOFRAN", "drugstructuredosagenumb": "4", "drugstructuredosageunit": "003", "drugdosagetext": "4 MILLIGRAM, Q8H, PRN", "drugadministrationroute": "048", "drugindication": "NAUSEA", "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "PHENERGAN", "drugdosageform": "SYRUP", "drugindication": "VOMITING", "activesubstance": { "activesubstancename": "PROMETHAZINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA083312" ], "brand_name": [ "PHENERGAN" ], "generic_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0641-6082", "0641-6083", "0641-6084", "0641-6085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "rxcui": [ "992460", "992462", "992858", "992876" ], "spl_id": [ "a64f0625-8d56-4994-8908-13614ca7b09f", "7d6e64fc-bbf2-4ea9-b866-8115c448e687" ], "spl_set_id": [ "6f7e47cc-f823-4336-8107-f980e3049617", "481866da-a712-48a5-853f-8e84aacaab6d" ], "package_ndc": [ "0641-6082-01", "0641-6082-25", "0641-6083-01", "0641-6083-25", "0641-6084-01", "0641-6084-25", "0641-6085-01", "0641-6085-25" ], "unii": [ "R61ZEH7I1I" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEVOCARNITINE.", "drugstructuredosagenumb": "330", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "6", "drugintervaldosagedefinition": "805", "drugdosagetext": "330 MILLIGRAM, Q6H", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "LEVOCARNITINE" }, "openfda": { "application_number": [ "ANDA076858", "NDA020182", "ANDA212533", "NDA019257", "ANDA217896", "ANDA075861", "ANDA075567", "ANDA076851", "ANDA211676", "ANDA217430", "NDA018948", "ANDA216384" ], "brand_name": [ "LEVOCARNITINE", "CARNITOR", "CARNITOR SF" ], "generic_name": [ "LEVOCARNITINE", "LEVOCARNITINE ORAL" ], "manufacturer_name": [ "Rising Pharma Holdings, Inc.", "Leadiant Biosciences, Inc.", "TRUPHARMA, LLC", "Baxter Healthcare Corporation", "American Regent, Inc.", "Hikma Pharmaceuticals USA Inc.", "ANI Pharmaceuticals, Inc.", "Saptalis Pharmaceuticals, LLC", "Devatis Inc." ], "product_ndc": [ "16571-762", "54482-147", "52817-830", "54482-148", "36000-368", "54482-145", "0517-1045", "0517-1075", "0143-9852", "64980-503", "70954-139", "70954-140", "71656-016", "73043-034", "54482-144", "70954-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "LEVOCARNITINE" ], "rxcui": [ "197448", "206345", "1791371", "315134", "206343", "2673428", "206346" ], "spl_id": [ "ad6d92d4-71c1-481a-a7cf-b2d551c5daad", "0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0", "2a4543d7-2fcf-548c-e063-6394a90af66e", "88041d93-8f95-4551-bba1-df964b092504", "1f38ab0d-ef89-4e92-990f-9da190057e17", "c1636127-9b6a-4443-81d9-e2607ae46e33", "114eaeda-8965-4c92-a3ff-15021b305464", "1bc5a420-8884-4b82-a39b-02064a59fde4", "3beded34-64c8-4a1d-80d4-02b3007233b9", "83851536-e1cf-4353-af71-abe714a48c9c", "30a343cc-caab-d417-e063-6394a90ad77b", "d1a8933e-ee3b-4183-a9bd-8c22eab71dfb", "24e9abdb-6e9d-4f27-9e0f-8e8a3a462615", "d259f663-b597-48bd-8420-3b5774ffc204" ], "spl_set_id": [ "0f749812-8f02-4eeb-91d9-5dd6fc9fa159", "cf801cc4-775e-433d-9d32-e5d9a98981d3", "05ab18c1-fb01-48fa-8f05-0200bb8a5edf", "dd904490-83f3-4cd3-bb6f-68e28509b4b6", "1f38ab0d-ef89-4e92-990f-9da190057e17", "b2cbc620-59fd-47b6-9e4b-7e3e31533a1c", "cc4da2c3-f939-444d-9b5b-a57b6051c190", "8f255df8-8a1f-4b4f-ae8c-2c80532ce8d4", "ada35959-e317-4161-ae79-3475096c679f", "18dc8eae-56c1-46ec-9d21-e17d7b2f91db", "75b43fb1-4486-48a0-b571-7754dce350a3", "79b6182c-ead5-4fdd-bafa-1afbc7a77906", "d2133bc3-9c15-48bd-8b16-b8995a6a14cd", "bfd0d39f-d3b2-4f0d-b7a2-071a545900f4" ], "package_ndc": [ "16571-762-09", "54482-147-01", "52817-830-04", "54482-148-01", "54482-148-02", "36000-368-01", "36000-368-10", "54482-145-08", "54482-145-09", "0517-1045-01", "0517-1045-05", "0517-1075-01", "0143-9852-01", "0143-9852-10", "64980-503-12", "70954-139-10", "70954-140-10", "71656-016-04", "71656-016-05", "71656-016-50", "71656-016-01", "71656-016-10", "71656-016-51", "71656-016-02", "73043-034-05", "54482-144-07", "70954-492-10" ], "nui": [ "M0003493", "N0000175903" ], "pharm_class_cs": [ "Carnitine [CS]" ], "pharm_class_epc": [ "Carnitine Analog [EPC]" ], "unii": [ "0G389FZZ9M" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20200217" } } } ] }