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United States · US · US:81665-101_c50830af-76fa-476a-a88d-50f38f9ecc42
LEVETIRACETAM
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOmnivium Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc118166510112120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12)
- ndc11816651016060 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A212688
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": {
"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": "81665-101_c50830af-76fa-476a-a88d-50f38f9ecc42",
"productndc": "81665-101",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212688",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "001",
"approval_date": "Jun 11, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "May 5, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "LEVETIRACETAM",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212688",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVETIRACETAM",
"start_marketing_date": "20230505",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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