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Xtandi

These highlights do not include all the information needed to use XTANDI safely and effectively. See full prescribing information for XTANDI. XTANDI (enzalutamide) capsules, for oral useXTANDI (enzalutamide) tablets, for oral useInitial U.S. Approval: 2012

Approved
Approval ID

b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2023

Manufacturers
FDA

Astellas Pharma US, Inc.

DUNS: 605764828

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

enzalutamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-0725
Application NumberNDA213674
Product Classification
M
Marketing Category
C73594
G
Generic Name
enzalutamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (1)

ENZALUTAMIDEActive
Quantity: 80 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB

enzalutamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-0625
Application NumberNDA213674
Product Classification
M
Marketing Category
C73594
G
Generic Name
enzalutamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (1)

ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB

enzalutamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-0125
Application NumberNDA203415
Product Classification
M
Marketing Category
C73594
G
Generic Name
enzalutamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (1)

ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB

enzalutamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-1725
Application NumberNDA213674
Product Classification
M
Marketing Category
C73594
G
Generic Name
enzalutamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (1)

ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB

enzalutamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0469-1125
Application NumberNDA203415
Product Classification
M
Marketing Category
C73594
G
Generic Name
enzalutamide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (1)

ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB

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Xtandi - FDA Drug Approval Details