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United States · US · US:50228-470_1ea253c3-3086-2b26-e063-6394a90a312e
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc115022847005500 TABLET, FILM COATED in 1 BOTTLE (50228-470-05)
- ndc1150228470101000 TABLET, FILM COATED in 1 BOTTLE (50228-470-10)
- ndc115022847012120 TABLET, FILM COATED in 1 BOTTLE (50228-470-12)
- ndc11502284703030 TABLET, FILM COATED in 1 BOTTLE (50228-470-30)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A215069
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": "50228-470_1ea253c3-3086-2b26-e063-6394a90a312e",
"productndc": "50228-470",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215069",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "001",
"approval_date": "Jun 11, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "002",
"approval_date": "Jun 11, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "003",
"approval_date": "May 27, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "004",
"approval_date": "May 27, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215069",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20220527",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N03AX14.
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