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United States · US · US:58657-860_47cfd9a6-663a-7cc6-e063-6294a90a4666
LEVETIRACETAM
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMethod Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1158657860011 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
- ndc11586578601010 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
- ndc11586578602525 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A209781
AP
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": "INTRAVENOUS",
"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": "58657-860_47cfd9a6-663a-7cc6-e063-6294a90a4666",
"productndc": "58657-860",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209781",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/5ML (100MG/ML)",
"product_no": "001",
"approval_date": "Mar 20, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "LEVETIRACETAM",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA209781",
"marketing_category": "ANDA",
"nonproprietary_name": "levetiracetam",
"start_marketing_date": "20251215",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AX14.
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