CAPLYTA
- Product NDC
- 72060-142
- 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
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 72060-142-07 | 7 CAPSULE in 1 BOTTLE (72060-142-07) | 20211101 | | Yes | Historical |
| 72060-142-40 | 30 CAPSULE in 1 BOTTLE (72060-142-40) | 20220401 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| db730b06-6351-47fd-8183-e61e61bbead5 | 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 |