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Lurasidone Hydrochloride

LURASIDONE HYDROCHLORIDE TABLETS. 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

1989d512-e568-468f-e063-6294a90a5c22

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 15, 2025

Manufacturers
FDA

Golden State Medical Supply, Inc.

DUNS: 603184490

Products 3

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 Code51407-838
Application NumberANDA208058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification

INGREDIENTS (8)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB

Lurasidone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51407-837
Application NumberANDA208058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification

INGREDIENTS (8)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB

Lurasidone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51407-836
Application NumberANDA208058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lurasidone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification

INGREDIENTS (8)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LURASIDONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB

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Lurasidone Hydrochloride - FDA Drug Approval Details