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United States · US · US:14335-420_4a887373-339e-1795-e063-6394a90a17dc
Brivaracetam
Orange BookUNIISPLATC N03AX23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHainan Poly Pharm. Co., Ltd.
CountryUS (United States)
ATC codeN03AX23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11143354201010 VIAL, GLASS in 1 CARTON (14335-420-10) / 5 mL in 1 VIAL, GLASS (14335-420-01)
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": "14335-420_4a887373-339e-1795-e063-6394a90a17dc",
"productndc": "14335-420",
"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",
"start_marketing_date": "20260221",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX23.
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