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United States · US · US:72673-031_4a887cf9-ddd0-b8ce-e063-6294a90afc47

brivaracetam

Orange BookUNIISPLATC N03AX23

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZhejiang Poly Pharm. Co., Ltd.
CountryUS (United States)
ATC codeN03AX23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7267303110
    1 BOTTLE in 1 CARTON (72673-031-10) / 300 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
U863JGG2IA
BRIVARACETAM
RxCUI 1739745
Orange Book
A218494
AA
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": "ORAL",
  "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": "72673-031_4a887cf9-ddd0-b8ce-e063-6294a90afc47",
  "productndc": "72673-031",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "218494",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "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/mL",
  "application_number": "ANDA218494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "brivaracetam",
  "start_marketing_date": "20260221",
  "active_numerator_strength": "10"
}

Related drugs

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