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United States · US · US:71921-410_7957cc22-2e0f-489d-9fa1-99520f615934

Brivaracetam oral Solution

Orange BookUNIISPLATC N03AX23

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

Identification

ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeN03AX23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7192141072
    1 BOTTLE in 1 CARTON (71921-410-72) / 300 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
U863JGG2IA
BRIVARACETAM
RxCUI 1739745
Orange Book
A220385
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": "71921-410_7957cc22-2e0f-489d-9fa1-99520f615934",
  "productndc": "71921-410",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "220385",
    "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 oral Solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA220385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brivaracetam oral",
  "start_marketing_date": "20260224",
  "active_numerator_strength": "10"
}

Related drugs

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