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United States · US · US:13668-300_724c2e0f-2d55-4a25-a514-125371becd21
LEVETIRACETAM
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111366830005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-05)
- ndc111366830012120 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-12)
- ndc111366830025250 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-25)
- ndc11136683006060 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-60)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A091338
ABAB
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": "13668-300_724c2e0f-2d55-4a25-a514-125371becd21",
"productndc": "13668-300",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "091338",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "May 29, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "May 29, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "LEVETIRACETAM",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091338",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVETIRACETAM",
"start_marketing_date": "20260130",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code N03AX14.
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