Briviact

Orange BookUNIISPLATC N03AX23

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

Identification

ManufacturerUCB, Inc.

CountryUS (United States)

ATC codeN03AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5047497075
10 VIAL, GLASS in 1 CARTON (50474-970-75) / 5 mL in 1 VIAL, GLASS (50474-970-63)

Annotations

UNII (FDA Substance ID)

U863JGG2IA

BRIVARACETAM

RxCUI 1739745

Orange Book

N205837

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": {
    "3cf2f439-0e97-443e-8e33-25ecef616f6c": {
      "match": "brand_token",
      "title": "BRIVIACT (BRIVARACETAM) TABLET, FILM COATED BRIVIACT (BRIVARACETAM) SOLUTION BRIVIACT (BRIVARACETAM) INJECTION, SUSPENSION [UCB, INC.]",
      "spl_version": "26",
      "published_date": "2026-05-14"
    }
  },
  "productid": "50474-970_51b3e2db-678a-dd8b-e063-6394a90aed7d",
  "productndc": "50474-970",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "205837",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "May 12, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIVARACETAM",
  "proprietary_name": "Briviact",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA205837",
  "marketing_category": "NDA",
  "nonproprietary_name": "brivaracetam",
  "start_marketing_date": "20160512",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N03AX23.

Access this data programmatically

Query Briviact and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs