Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CAPLYTA
Product Details
NDC Product Code
72060-142Application Number
NDA209500Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 22, 2022LumateperoneActive
Code: 70BSQ12069Class: ACTIBQuantity: 42 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CAPLYTA
Product Details
NDC Product Code
72060-110Application Number
NDA209500Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 22, 2022LumateperoneActive
Code: 70BSQ12069Class: ACTIBQuantity: 10.5 mg in 1 1
CAPLYTA
Product Details
NDC Product Code
72060-121Application Number
NDA209500Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 22, 2022LumateperoneActive
Code: 70BSQ12069Class: ACTIBQuantity: 21 mg in 1 1