Lurasidone hydrochloride
Lurasidone Hydrochloride Tablets
Approved
Approval ID
0f5f8228-1304-4981-8577-029136627260
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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
NDC Product Code70771-1737
Application NumberANDA208052
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameLurasidone hydrochloride
INGREDIENTS (14)
LURASIDONE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Lurasidone hydrochloride
PRODUCT DETAILS
NDC Product Code70771-1736
Application NumberANDA208052
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameLurasidone hydrochloride
INGREDIENTS (13)
LURASIDONE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Lurasidone hydrochloride
PRODUCT DETAILS
NDC Product Code70771-1738
Application NumberANDA208052
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameLurasidone hydrochloride
INGREDIENTS (13)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
Lurasidone hydrochloride
PRODUCT DETAILS
NDC Product Code70771-1735
Application NumberANDA208052
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameLurasidone hydrochloride
INGREDIENTS (13)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
Lurasidone hydrochloride
PRODUCT DETAILS
NDC Product Code70771-1734
Application NumberANDA208052
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameLurasidone hydrochloride
INGREDIENTS (14)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT