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United States · US · US:69452-412_4fae5b8b-e3f2-f9a9-e063-6294a90ab8f3
LEVETIRACETAM
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116945241288473 mL in 1 BOTTLE (69452-412-88)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A079120
AA
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": "69452-412_4fae5b8b-e3f2-f9a9-e063-6294a90ab8f3",
"productndc": "69452-412",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "079120",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Jan 16, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "LEVETIRACETAM",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA079120",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVETIRACETAM",
"start_marketing_date": "20240718",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX14.
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