Lurasidone hydrochloride
LURASIDONE
Approved
Approval ID
9b512af1-98ab-1242-10e8-9534a002306e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2022
Manufacturers
FDA
Dr. Reddys Laboratories Inc
DUNS: 802315887
Products 4
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 Code43598-351
Application NumberANDA208047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-352
Application NumberANDA208047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (9)
LURASIDONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-354
Application NumberANDA208047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (11)
LURASIDONE HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-353
Application NumberANDA208047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (9)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT