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United States · US · US:44567-501_5d75a4ee-4a82-48d9-809b-eabea28c6e96
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11445675011010 BAG in 1 CARTON (44567-501-10) / 100 mL in 1 BAG (44567-501-01)
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
N202543
APAPAP
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": "44567-501_5d75a4ee-4a82-48d9-809b-eabea28c6e96",
"productndc": "44567-501",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "202543",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "500MG/100ML (5MG/ML)",
"product_no": "001",
"approval_date": "Nov 9, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1GM/100ML (10MG/ML)",
"product_no": "002",
"approval_date": "Nov 9, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "1.5GM/100ML (15MG/ML)",
"product_no": "003",
"approval_date": "Nov 9, 2011"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "004",
"approval_date": "Dec 14, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/mL",
"application_number": "NDA202543",
"marketing_category": "NDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20200824",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N03AX14.
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