FDA.reportPublic FDA data

Caplyta 42 MG Oral Capsule

RxCUI
2275613
RxNorm name
Caplyta 42 MG Oral Capsule
Display name
Caplyta 42 MG Oral Capsule
Full name
Caplyta 42 MG Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPLYTALUMATEPERONEIntra-Cellular Therapies, Incdb730b06-6351-47fd-8183-e61e61bbead52025-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2275613

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
db730b06-6351-47fd-8183-e61e61bbead5CAPLYTA 42 MG Oral Capsule [PSN] · lumateperone 42 MG Oral Capsule [Caplyta] [SBD] · Caplyta 42 MG (equivalent to lumateperone tosylate 60 MG) Oral Capsule [SY] · Caplyta 42 MG Oral Capsule [SY]427These 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: 201920250620