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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 205837 | UCB INC | 2016-02-18 | 1 |
| NDA 205838 | UCB INC | 2016-02-18 | 1 |
| NDA 205836 | UCB INC | 2016-02-18 | 5 |
| ANDA 214748 | SUNSHINE | 2022-06-09 | 5 |
| ANDA 214501 | ZYDUS PHARMS | 2022-10-03 | 10 |
| ANDA 214848 | AUROBINDO PHARMA LTD | 2023-01-06 | 5 |
| ANDA 214921 | MSN | 2025-11-13 | 9 |
| ANDA 214922 | MSN | 2026-02-19 | 1 |
| ANDA 220385 | REGCON HOLDINGS | 2026-02-23 | 1 |
| ANDA 214875 | APOTEX | 2026-02-23 | 5 |
| ANDA 218249 | HAINAN POLY | 2026-02-23 | 2 |
| ANDA 218494 | ZHEJIANG POLY PHARM | 2026-02-23 | 2 |
| ANDA 214880 | MICRO LABS | 2026-02-23 | 1 |
| ANDA 219772 | ALKEM LABS LTD | 2026-02-23 | 1 |
| ANDA 220164 | LUPIN | 2026-02-23 | 1 |
| ANDA 214924 | MSN | 2026-02-23 | 1 |
| ANDA 219952 | SCIEGEN PHARMS | 2026-07-01 | 10 |
| ANDA 220288 | AUROBINDO PHARMA | 2026-08-10 | 1 |
Official labeling on DailyMed
- BRIVARACETAM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2026-08-25
- BRIVIACT (BRIVARACETAM) TABLET, FILM COATED BRIVIACT (BRIVARACETAM) SOLUTION BRIVIACT (BRIVARACETAM) INJECTION, SUSPENSION [UCB, INC.] · version 27 · 2026-08-21
- BRIVARACETAM SOLUTION [AUROBINDO PHARMA LIMITED] · version 2 · 2026-08-13
- BRIVARACETAM TABLET, FILM COATED [SOLARIS PHARMA CORPORATION] · version 3 · 2026-08-04
- BRIVARACETAM TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] · version 1 · 2026-07-24
- BRIVARACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 4 · 2026-07-16
- BRIVARACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 1 · 2026-07-16
- BRIVARACETAM TABLET, FILM COATED [AVKARE] · version 1 · 2026-05-11
- BRIVARACETAM SOLUTION [LUPIN PHARMACEUTICALS, INC.] · version 5 · 2026-03-09
- BRIVARACETAM (BRIVARACETAM) INJECTION [MICRO LABS LIMITED] · version 2 · 2026-03-02
- BRIVARACETAM INJECTION, SOLUTION [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2026-02-26
- BRIVARACETAM TABLET [APOTEX CORP.] · version 2 · 2026-02-26
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.