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United States · US · US:50474-599_38534148-3717-03b3-e063-6394a90a0f1e
Keppra
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUCB, Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11504745996660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
N022285
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "44YRR34555",
"rxcui": "114477",
"inchikey": "HPHUVLMMVZITSG-LURJTMIESA-N",
"display_name": "LEVETIRACETAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3ca9df05-a506-4ec8-a4fe-320f1219ab21": {
"match": "brand_token",
"title": "KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]",
"spl_version": "36",
"published_date": "2026-01-29"
}
},
"productid": "50474-599_38534148-3717-03b3-e063-6394a90a0f1e",
"productndc": "50474-599",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "022285",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Sep 12, 2008"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "Feb 12, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Keppra",
"active_ingred_unit": "mg/1",
"application_number": "NDA022285",
"marketing_category": "NDA",
"nonproprietary_name": "levetiracetam",
"start_marketing_date": "20090401",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code N03AX14.
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