Active ingredient
Brexpiprazole
14 finished FDA listings contain Brexpiprazole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BREXPIPRAZOLE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- .25 mg/1 · .5 mg/1 · 1 mg/1 · 2 mg/1 · 3 mg/1 · 4 mg/1
- Brand names in FDA listings
- Rexulti
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1658314
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 205422 | OTSUKA | 2015-07-10 | 8 |
| ANDA 213718 | AJANTA PHARMA LTD | 2023-02-03 | 6 |
Official labeling on DailyMed
- REXULTI (BREXPIPRAZOLE) TABLET [REMEDYREPACK INC.] · version 6 · 2026-06-04
- REXULTI (BREXPIPRAZOLE) TABLET REXULTI (BREXPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.] · version 26 · 2026-05-28
- BREXPIPRAZOLE TABLET [AJANTA PHARMA USA INC.] · version 4 · 2023-02-22
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.