CAPLYTA®
(lumateperone)
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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
CAPLYTA® (lumateperone)
Medical Information
CAPLYTA - Ingredients
Last Updated: 11/07/2025
SUMMARY
- The active ingredient in CAPLYTA is lumateperone, which is the free base of the salt form of lumateperone tosylate.1
- CAPLYTA 42 mg, 21 mg, and 10.5 mg is equivalent to lumateperone tosylate 60 mg, 30 mg, and 15 mg, respectively.
- The inactive ingredients present in CAPLYTA capsules are mannitol, croscarmellose sodium, talc, and magnesium stearate.1
- The CAPLYTA capsules contain gelatin and titanium dioxide. Additional colorants are also present in the 42 mg and 10.5 mg capsules, while the 21 mg capsules do not contain additional colorants.1
- CAPLYTA 42 mg capsules contain FD&C Blue #1, and FD&C Red #3
- CAPLYTA 10.5 mg capsules contain black iron oxide, red iron oxide, and FD&C Red #3
- The CAPLYTA capsules are imprinted, and the imprinting contains (in very small amounts): shellac glaze (modified) in SD-45, black iron oxide (irradiated), N-butyl alcohol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.
product packaging
- CAPLYTA is available in a capsule formulation, with each bottle containing 30 capsules.1 The specific capsule characteristics are in the Table: Specifications of Available Dosage Forms of CAPLYTA Capsules
| Capsule strength | Capsule color | Imprint code | Package configuration | NDC code |
|---|---|---|---|---|
| 42 mg | Blue cap and opaque white body | ITI-007 42 mg | Bottle of 30 | 72060-142-40 |
| 21 mg | Opaque white cap and body | ITI-007 21 mg | Bottle of 30 | 72060-121-40 |
| 10.5 mg | Opaque light pink cap and body | ITI-007 10.5 mg | Bottle of 30 | 72060-110-40 |
References
| 1 | CAPLYTA® (lumateperone) [Prescribing Information]. Bedminster, NJ: Intra-Cellular Therapies, Inc; https://www.intracellulartherapies.com/docs/caplyta_pi.pdf |