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Briviact

brivaracetam · Tablet, Film Coated

Prescription NDA Schedule CV TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Briviact
Generic name
brivaracetam
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
UCB, Inc.
Product type
Human Prescription Drug
DEA schedule
CV
Active ingredients
5
NDC product codes
5
Packages
11
Data completeness
61% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Brivaracetam 10 mg/1 1739761 View
Brivaracetam 100 mg/1 1739761 View
Brivaracetam 25 mg/1 1739761 View
Brivaracetam 50 mg/1 1739761 View
Brivaracetam 75 mg/1 1739761 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
16

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Epoxide Hydrolase Inhibitors [MoA] MoA 6 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205836
Application type
NDA · New Drug Application
Approval date
February 18, 2016
Sponsor
UCB INC
Products on application
5
Submissions recorded
8
Products approved under application 205836.
Product Trade name Form Strength Ingredient Status TE Flags
205836-001 BRIVIACT TABLET BRIVARACETAM Prescription AB RLD
205836-002 BRIVIACT TABLET BRIVARACETAM Prescription AB RLD
205836-003 BRIVIACT TABLET BRIVARACETAM Prescription AB RLD
205836-004 BRIVIACT TABLET BRIVARACETAM Prescription AB RLD
205836-005 BRIVIACT TABLET BRIVARACETAM Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
6911461 February 21, 2026 001 Yes U-2295 February 25, 2016
6911461 February 21, 2026 002 Yes U-2295 February 25, 2016
6911461 February 21, 2026 003 Yes U-2295 February 25, 2016
6911461 February 21, 2026 004 Yes U-2295 February 25, 2016
6911461 February 21, 2026 005 Yes U-2295 February 25, 2016
10729653 April 9, 2030 001 No August 18, 2020
10729653 April 9, 2030 002 No August 18, 2020
10729653 April 9, 2030 003 No August 18, 2020
10729653 April 9, 2030 004 No August 18, 2020
10729653 April 9, 2030 005 No August 18, 2020

Approval history

Source: Drugs@FDA
Most recent submissions on application 205836.
Type No. Action Status Date Review
Supplement 17 Labeling Approved August 28, 2025 Standard
Supplement 14 Labeling Approved May 17, 2023 Standard
Supplement 11 Labeling Approved September 2, 2021 Standard
Supplement 9 Efficacy Approved August 27, 2021 Standard
Supplement 5 Efficacy Approved May 10, 2018 Standard
Supplement 3 Efficacy Approved September 14, 2017 Standard
Supplement 1 Labeling Approved June 3, 2016 Standard
Original application 1 Type 1 - New Molecular Entity Approved February 18, 2016 Standard

Review documents

  • 0 · Supplement · September 2, 2025
  • 0 · Supplement · September 2, 2025
  • 0 · Supplement · August 29, 2025
  • 0 · Supplement · May 18, 2023
  • 0 · Supplement · May 18, 2023
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · September 3, 2021
  • 0 · Supplement · August 31, 2021
  • 0 · Supplement · August 31, 2021
  • 0 · Supplement · May 16, 2018
  • 0 · Supplement · May 14, 2018
  • 0 · Supplement · September 19, 2017
  • 0 · Supplement · September 15, 2017
  • 0 · Original application · April 7, 2017
  • 0 · Supplement · June 6, 2016
  • 0 · Supplement · June 6, 2016
  • 0 · Original application · March 30, 2016
  • 0 · Original application · February 19, 2016
  • 0 · Original application · February 19, 2016

Adverse event reports

Source: openFDA FAERS
8,940
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BRIVARACETAM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II June 2, 2021 Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50474-370-66 50474-370 UCB, Inc. 1 BOTTLE in 1 CARTON (50474-370-66) / 60 TABLET, FILM COATED in 1 BOTTLE May 12, 2016
50474-470-09 50474-470 UCB, Inc. 100 BLISTER PACK in 1 CARTON (50474-470-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2016
50474-470-14 50474-470 UCB, Inc. 1 BLISTER PACK in 1 CARTON (50474-470-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2016
50474-470-66 50474-470 UCB, Inc. 1 BOTTLE in 1 CARTON (50474-470-66) / 60 TABLET, FILM COATED in 1 BOTTLE May 12, 2016
50474-570-09 50474-570 UCB, Inc. 100 BLISTER PACK in 1 CARTON (50474-570-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2016
50474-570-14 50474-570 UCB, Inc. 1 BLISTER PACK in 1 CARTON (50474-570-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2016
50474-570-66 50474-570 UCB, Inc. 1 BOTTLE in 1 CARTON (50474-570-66) / 60 TABLET, FILM COATED in 1 BOTTLE May 12, 2016
50474-670-66 50474-670 UCB, Inc. 1 BOTTLE in 1 CARTON (50474-670-66) / 60 TABLET, FILM COATED in 1 BOTTLE May 12, 2016
50474-770-09 50474-770 UCB, Inc. 100 BLISTER PACK in 1 CARTON (50474-770-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2016
50474-770-14 50474-770 UCB, Inc. 1 BLISTER PACK in 1 CARTON (50474-770-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2016
50474-770-66 50474-770 UCB, Inc. 1 BOTTLE in 1 CARTON (50474-770-66) / 60 TABLET, FILM COATED in 1 BOTTLE May 12, 2016
50474-370 50474-370 UCB, Inc. — May 12, 2016
50474-470 50474-470 UCB, Inc. — May 12, 2016
50474-570 50474-570 UCB, Inc. — May 12, 2016
50474-670 50474-670 UCB, Inc. — May 12, 2016
50474-770 50474-770 UCB, Inc. — May 12, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.