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
5047467066
1 BOTTLE in 1 CARTON (50474-670-66) / 60 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

U863JGG2IA

BRIVARACETAM

RxCUI 1739745

Orange Book

N205836

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": {
    "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": "50474-670_51b3e2db-678a-dd8b-e063-6394a90aed7d",
  "productndc": "50474-670",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205836",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 12, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "May 12, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "May 12, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "May 12, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "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/1",
  "application_number": "NDA205836",
  "marketing_category": "NDA",
  "nonproprietary_name": "brivaracetam",
  "start_marketing_date": "20160512",
  "active_numerator_strength": "75"
}

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