Lurasidone Hydrochloride
These highlights do not include all the information needed to use LURASIDONE HYDROCHLORIDE safely and effectively. See full prescribing information for LURASIDONE HYDROCHLORIDE. LURASIDONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
76c055aa-d96a-42e5-a670-1db63b9c1dd6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Cipla USA, Inc.
DUNS: 078719707
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 Code69097-939
Application NumberANDA208028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (10)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
lurasidone hydrochlorideActive
Quantity: 60 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-942
Application NumberANDA208028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (10)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-941
Application NumberANDA208028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (10)
LURASIDONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-937
Application NumberANDA208028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (10)
LURASIDONE HYDROCHLORIDEActive
Quantity: 120 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
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
Lurasidone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-938
Application NumberANDA208028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (12)
LURASIDONE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT