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

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
72060-142-4030 CAPSULE in 1 BOTTLE (72060-142-40) 20220401NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
db730b06-6351-47fd-8183-e61e61bbead5These 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: 2019Intra-Cellular Therapies, Inc2026-04-30HUMAN PRESCRIPTION DRUG LABEL26