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United States · US · US:63187-360_e47bfa3c-961e-45d8-a06a-d2d2a91fe115
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631873603030 TABLET, FILM COATED in 1 BOTTLE (63187-360-30)
- ndc11631873606060 TABLET, FILM COATED in 1 BOTTLE (63187-360-60)
- ndc11631873609090 TABLET, FILM COATED in 1 BOTTLE (63187-360-90)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A078154
ABABAB
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": "63187-360_e47bfa3c-961e-45d8-a06a-d2d2a91fe115",
"productndc": "63187-360",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078154",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jan 15, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jan 15, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Jan 15, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078154",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20090101",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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