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United States · US · US:0264-1509_c37794a6-677a-4669-83c6-8fbff7ab24fd
Levetiracetam
Orange BookUNIISPLATC N03AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11026415099024 CONTAINER in 1 CASE (0264-1509-90) / 100 mL in 1 CONTAINER
Annotations
UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A209705
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": "0264-1509_c37794a6-677a-4669-83c6-8fbff7ab24fd",
"productndc": "0264-1509",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209705",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/100ML (5MG/ML)",
"product_no": "001",
"approval_date": "Feb 27, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/100ML (10MG/ML)",
"product_no": "002",
"approval_date": "Feb 27, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1.5GM/100ML (15MG/ML)",
"product_no": "003",
"approval_date": "Feb 27, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVETIRACETAM",
"proprietary_name": "Levetiracetam",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209705",
"marketing_category": "ANDA",
"nonproprietary_name": "Levetiracetam",
"start_marketing_date": "20240513",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N03AX14.
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