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United States · US · US:0904-7265_0253fb34-3555-4f12-9442-0a9be7bb6878
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1109047265925 TRAY in 1 CASE (0904-7265-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)
- ndc1109047265933 TRAY in 1 CASE (0904-7265-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)
- ndc1109047265944 TRAY in 1 CASE (0904-7265-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A201157
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": "0904-7265_0253fb34-3555-4f12-9442-0a9be7bb6878",
"productndc": "0904-7265",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "201157",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Jun 4, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA201157",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVETIRACETAM",
"start_marketing_date": "20150604",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX14.
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