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
NDC Product Code0469-0725
Application NumberNDA213674
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 20, 2023
Generic Nameenzalutamide
INGREDIENTS (1)
ENZALUTAMIDEActive
Quantity: 80 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB
enzalutamide
PRODUCT DETAILS
NDC Product Code0469-0625
Application NumberNDA213674
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 20, 2023
Generic Nameenzalutamide
INGREDIENTS (1)
ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB
enzalutamide
PRODUCT DETAILS
NDC Product Code0469-0125
Application NumberNDA203415
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 20, 2023
Generic Nameenzalutamide
INGREDIENTS (1)
ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB
enzalutamide
PRODUCT DETAILS
NDC Product Code0469-1725
Application NumberNDA213674
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 20, 2023
Generic Nameenzalutamide
INGREDIENTS (1)
ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB
enzalutamide
PRODUCT DETAILS
NDC Product Code0469-1125
Application NumberNDA203415
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 20, 2023
Generic Nameenzalutamide
INGREDIENTS (1)
ENZALUTAMIDEActive
Quantity: 40 mg in 1 1
Code: 93T0T9GKNU
Classification: ACTIB