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United States · US · US:50474-596_4974b225-87ca-610e-e063-6294a90ad20a
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
- ndc115047459640120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-596-40)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
N021035
ABABABAB
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": "50474-596_4974b225-87ca-610e-e063-6294a90ad20a",
"productndc": "50474-596",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021035",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Nov 30, 1999"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Nov 30, 1999"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Nov 30, 1999"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1GM",
"product_no": "004",
"approval_date": "Jan 6, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Keppra",
"active_ingred_unit": "mg/1",
"application_number": "NDA021035",
"marketing_category": "NDA",
"nonproprietary_name": "levetiracetam",
"start_marketing_date": "20000424",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code N03AX14.
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