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United States · US · US:42571-370_4b90f695-a995-1b76-e063-6294a90a7615
BRIVARACETAM
Orange BookUNIISPLATC N03AX23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN03AX23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11425713709910 VIAL in 1 CARTON (42571-370-99) / 5 mL in 1 VIAL (42571-370-92)
Annotations
UNII (FDA Substance ID)
U863JGG2IA
BRIVARACETAM
RxCUI 1739745
Orange Book
A214880
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": "42571-370_4b90f695-a995-1b76-e063-6294a90a7615",
"productndc": "42571-370",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214880",
"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": "ANDA214880",
"marketing_category": "ANDA",
"nonproprietary_name": "BRIVARACETAM",
"start_marketing_date": "20260301",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AX23.
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