MedPath
FDA Product

Briviact

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Briviact

50474-970

Regulatory Information

50474-970

NDA205837

C73594

May 24, 2023

USA

These highlights do not include all the information needed to use BRIVIACT safely and effectively. See full prescribing information for BRIVIACT. BRIVIACT (brivaracetam) tablets, for oral use, CV BRIVIACT (brivaracetam) oral solution, CV BRIVIACT (brivaracetam) injection, for intravenous use, CV Initial U.S. Approval: 2016

HUMAN PRESCRIPTION DRUG LABEL

19

Company Information

UCB, Inc.

028526403

Active Ingredients

brivaracetam

Quantity: 50 mg in 5 mL

Code: U863JGG2IA

Class Code: ACTIB

sodium acetate

Code: 4550K0SC9B

Class Code: IACT

acetic acid

Code: Q40Q9N063P

Class Code: IACT

sodium chloride

Code: 451W47IQ8X

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

brivaracetam

Code: U863JGG2IA

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