CAPLYTA
- Product NDC
- 72060-121
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lumateperone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Intra-Cellular Therapies, Inc
- Application
- NDA209500
- Marketing category
- NDA
- Substance
- LUMATEPERONE
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 72060-121-07 | 7 CAPSULE in 1 BOTTLE (72060-121-07) | 2023-06-01 | Yes | Historical | |
| 72060-121-40 | 30 CAPSULE in 1 BOTTLE (72060-121-40) | 2022-08-09 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use CAPLYTA safely and effectively. See full prescribing information for CAPLYTA. CAPLYTA ® (lumateperone) capsules, for oral use Initial U.S. Approval: 2019 | Intra-Cellular Therapies, Inc | 2026-04-30 | HUMAN PRESCRIPTION DRUG LABEL | 26 |