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Active ingredient

Brivaracetam

62 finished FDA listings contain Brivaracetam as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
BRIVARACETAM
Dosage forms
Injection, Injection, Solution, Injection, Suspension, Solution, Tablet, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
17
Strengths listed
10 mg/1 · 10 mg/ml · 100 mg/1 · 25 mg/1 · 50 mg/1 · 50 mg/5ml · 75 mg/1
Brand names in FDA listings
Brivaracetam, Brivaracetam Oral Solution, Briviact

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1739745

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 205837UCB INC2016-02-181
NDA 205838UCB INC2016-02-181
NDA 205836UCB INC2016-02-185
ANDA 214748SUNSHINE2022-06-095
ANDA 214501ZYDUS PHARMS2022-10-0310
ANDA 214848AUROBINDO PHARMA LTD2023-01-065
ANDA 214921MSN2025-11-139
ANDA 214922MSN2026-02-191
ANDA 220385REGCON HOLDINGS2026-02-231
ANDA 214875APOTEX2026-02-235
ANDA 218249HAINAN POLY2026-02-232
ANDA 218494ZHEJIANG POLY PHARM2026-02-232
ANDA 214880MICRO LABS2026-02-231
ANDA 219772ALKEM LABS LTD2026-02-231
ANDA 220164LUPIN2026-02-231
ANDA 214924MSN2026-02-231
ANDA 219952SCIEGEN PHARMS2026-07-0110
ANDA 220288AUROBINDO PHARMA2026-08-101

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.