Brivaracetam

Orange BookUNIISPLATC N03AX23

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeN03AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050547246
60 TABLET in 1 BOTTLE (60505-4724-6)

Annotations

UNII (FDA Substance ID)

U863JGG2IA

BRIVARACETAM

RxCUI 1739745

Orange Book

A214875

ABABABABAB

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": "60505-4724_a2119162-90a5-0d0c-9d3b-6364bf087960",
  "productndc": "60505-4724",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214875",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Feb 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Feb 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Feb 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "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/1",
  "application_number": "ANDA214875",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brivaracetam",
  "start_marketing_date": "20260224",
  "active_numerator_strength": "25"
}

Related drugs

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