CAPLYTA
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
Approved
Approval ID
2ecc0f15-1d46-4b87-a6ae-aebb7b38bc73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lumateperone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70518-3497
Application NumberNDA209500
Product Classification
M
Marketing Category
C73594
G
Generic Name
lumateperone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (6)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LUMATEPERONEActive
Quantity: 42 mg in 1 1
Code: 70BSQ12069
Classification: ACTIB