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United States · US · US:69367-333_18d684d2-22a4-497a-ab10-f35ef53408ce
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWestminster Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11693673336060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-333-60)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A205130
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": "69367-333_18d684d2-22a4-497a-ab10-f35ef53408ce",
"productndc": "69367-333",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "205130",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Nov 27, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "Nov 27, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205130",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20210930",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code N03AX14.
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