🇺🇸
United States · US · US:0121-1075_c0702161-ae73-4aac-b6fd-fb3fa7c841b8
Brivaracetam
Orange BookUNIISPLATC N03AX23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeN03AX23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11012110750210 VIAL, GLASS in 1 CARTON (0121-1075-02) / 5 mL in 1 VIAL, GLASS (0121-1075-55)
Annotations
UNII (FDA Substance ID)
U863JGG2IA
BRIVARACETAM
RxCUI 1739745
Orange Book
A218249
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U863JGG2IA",
"rxcui": "1739745",
"inchikey": "MSYKRHVOOPPJKU-BDAKNGLRSA-N",
"display_name": "BRIVARACETAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5115c5b4-7a23-89f2-e063-6294a90a222a": {
"match": "brand_token",
"title": "BRIVARACETAM TABLET, FILM COATED [AVKARE]",
"spl_version": "1",
"published_date": "2026-05-11"
}
},
"productid": "0121-1075_c0702161-ae73-4aac-b6fd-fb3fa7c841b8",
"productndc": "0121-1075",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218249",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Feb 23, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIVARACETAM",
"proprietary_name": "Brivaracetam",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA218249",
"marketing_category": "ANDA",
"nonproprietary_name": "Brivaracetam Injection",
"start_marketing_date": "20260223",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX23.
Access this data programmatically
Query Brivaracetam and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.