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United States · US · US:68788-7884_330f748b-2260-4e6d-b48d-4499bf31d561
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878878841100 TABLET, FILM COATED in 1 BOTTLE (68788-7884-1)
- ndc11687887884220 TABLET, FILM COATED in 1 BOTTLE (68788-7884-2)
- ndc11687887884330 TABLET, FILM COATED in 1 BOTTLE (68788-7884-3)
- ndc11687887884660 TABLET, FILM COATED in 1 BOTTLE (68788-7884-6)
- ndc11687887884990 TABLET, FILM COATED in 1 BOTTLE (68788-7884-9)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A090515
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": "68788-7884_330f748b-2260-4e6d-b48d-4499bf31d561",
"productndc": "68788-7884",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090515",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Oct 8, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Oct 8, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Oct 8, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "004",
"approval_date": "Oct 8, 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": "ANDA090515",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20210329",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N03AX14.
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