Lurasidone Hydrochloride
These highlights do not include all the information needed to use LURASIDONE HYDROCHLORIDE TABLETS safely and effectively. See Full Prescribing Information for LURASIDONE HYDROCHLORIDE TABLETS. LURASIDONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
1cc441b3-0a23-4c68-a90e-436030b7daf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-496
Application NumberANDA213248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-497
Application NumberANDA213248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (10)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-498
Application NumberANDA213248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (8)
LURASIDONE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-495
Application NumberANDA213248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (8)
LURASIDONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-494
Application NumberANDA213248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (8)
LURASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT