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United States · US · US:67877-768_40d1180e-73b5-4e73-8d42-15b99313496f
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116787776805500 TABLET, FILM COATED in 1 BOTTLE (67877-768-05)
- ndc116787776812120 TABLET, FILM COATED in 1 BOTTLE (67877-768-12)
- ndc11678777683030 TABLET, FILM COATED in 1 BOTTLE (67877-768-30)
- ndc1167877768331 BLISTER PACK in 1 CARTON (67877-768-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A216375
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": {
"52fa0eec-3dd9-59ca-e063-6394a90a9791": {
"match": "brand_token",
"title": "LEVETIRACETAM TABLET, FILM COATED [INJECTA MEDCIAL LLC]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "67877-768_40d1180e-73b5-4e73-8d42-15b99313496f",
"productndc": "67877-768",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216375",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "May 27, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "May 27, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "May 27, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "004",
"approval_date": "May 27, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216375",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20220528",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N03AX14.
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