Active ingredient
Cariprazine
6 finished FDA listings contain Cariprazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CARIPRAZINE, CARIPRAZINE HYDROCHLORIDE
- Dosage forms
- Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- .5 mg/1 · .75 mg/1 · 1.5 mg/1 · 3 mg/1 · 4.5 mg/1 · 6 mg/1
- Brand names in FDA listings
- Vraylar
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1667655
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 204370 | ABBVIE | 2015-09-17 | 6 |
Official labeling on DailyMed
- VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED VRAYLAR (CARIPRAZINE) KIT [ALLERGAN, INC.] · version 32 · 2026-08-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.