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United States · US · US:80425-0566_45a04c5b-7c31-19bf-e063-6294a90aad27
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc118042505661120 TABLET in 1 BOTTLE (80425-0566-1)
- ndc11804250566230 TABLET in 1 BOTTLE (80425-0566-2)
- ndc11804250566360 TABLET in 1 BOTTLE (80425-0566-3)
- ndc11804250566490 TABLET in 1 BOTTLE (80425-0566-4)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A091491
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": "80425-0566_45a04c5b-7c31-19bf-e063-6294a90aad27",
"productndc": "80425-0566",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091491",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Dec 14, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Dec 14, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Dec 14, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "004",
"approval_date": "Dec 14, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091491",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20251210",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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