Active ingredient
Lumateperone
3 finished FDA listings contain Lumateperone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LUMATEPERONE, LUMATEPERONE TOSYLATE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10.5 mg/1 · 21 mg/1 · 42 mg/1
- Brand names in FDA listings
- Caplyta
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2275602
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 209500 | INTRA-CELLULAR | 2019-12-20 | 3 |
Official labeling on DailyMed
- CAPLYTA (LUMATEPERONE) CAPSULE [INTRA-CELLULAR THERAPIES, INC] · version 27 · 2026-06-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.