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United States · US · US:0615-8499_8d4105d5-1eda-42d1-b232-34b8b189e63a
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11061584990515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8499-05)
- ndc11061584992828 TABLET, FILM COATED in 1 BLISTER PACK (0615-8499-28)
- ndc11061584993930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8499-39)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A214815
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": "0615-8499_8d4105d5-1eda-42d1-b232-34b8b189e63a",
"productndc": "0615-8499",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214815",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Oct 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Oct 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Oct 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "004",
"approval_date": "Oct 7, 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": "ANDA214815",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20221007",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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