brivaracetam

Orange BookUNIISPLATC N03AX23

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeN03AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7319007560
60 TABLET, FILM COATED in 1 BOTTLE (73190-075-60)

Annotations

UNII (FDA Substance ID)

U863JGG2IA

BRIVARACETAM

RxCUI 1739745

Orange Book

A214921

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": "73190-075_5115cab3-6f99-9a71-e063-6294a90a694f",
  "productndc": "73190-075",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214921",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Nov 13, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIVARACETAM",
  "proprietary_name": "brivaracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214921",
  "marketing_category": "ANDA",
  "nonproprietary_name": "brivaracetam",
  "start_marketing_date": "20260505",
  "active_numerator_strength": "50"
}

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