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United States · US · US:50474-002_38cabb23-4e04-9a05-e063-6394a90a2a94
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
- ndc11504740026310 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
N021872
AP
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": "INTRAVENOUS",
"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": "50474-002_38cabb23-4e04-9a05-e063-6394a90a2a94",
"productndc": "50474-002",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "021872",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "500MG/5ML (100MG/ML)",
"product_no": "001",
"approval_date": "Jul 31, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Keppra",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021872",
"marketing_category": "NDA",
"nonproprietary_name": "levetiracetam",
"start_marketing_date": "20060823",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX14.
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