FDA.reportPublic FDA data

Xtandi

Product NDC
0469-0125
11-digit product format
004690125
Labeler code
0469
Product ID
0469-0125_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enzalutamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA203415
Marketing category
NDA
Marketing start
2012-08-31
Substance
ENZALUTAMIDE
Active strength
40 mg/1
Pharmacologic classes
Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xtandi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENZALUTAMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii93T0T9GKNU
Rxcui1307303, 1307309, 2390644, 2390646, 2390648, 2390650

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06830410-7a31-1c12-a87c-78c7b1a695cbProduct name220211208
64cacdcb-6ac9-4f6e-84ab-15ad5c3422eaProduct name120210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0469-0125-99Xtandi1 in 1 CARTONCAPSULE122
0469-0125-99Xtandi120 in 1 BOTTLECAPSULE12022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-0125-99EA - Each0469-0125f252e6bd-4db0-4ee6-a184-f2d8e2d22bdf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENZALUTAMIDEACTIVE INGREDIENT93T0T9GKNUXTANDI (ENZALUTAMIDE) CAPSULE [ASTELLAS PHARMA US, INC.]7
ENZALUTAMIDEACTIVE MOIETY93T0T9GKNUXTANDI (ENZALUTAMIDE) CAPSULE [ASTELLAS PHARMA US, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-0125XTANDI (ENZALUTAMIDE) CAPSULE XTANDI (ENZALUTAMIDE) TABLET [ASTELLAS PHARMA US, INC.]21Current NDC, Legacy NDC, 2 package rows20250406_b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307303enzalutamide 40 MG Oral CapsulePSNb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390644enzalutamide 40 MG Oral TabletPSNb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390648enzalutamide 80 MG Oral TabletPSNb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
1307309Xtandi 40 MG Oral CapsulePSNb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390646Xtandi 40 MG Oral TabletPSNb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390650Xtandi 80 MG Oral TabletPSNb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
1307309enzalutamide 40 MG Oral Capsule [Xtandi]SBDb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390646enzalutamide 40 MG Oral Tablet [Xtandi]SBDb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390650enzalutamide 80 MG Oral Tablet [Xtandi]SBDb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
1307303enzalutamide 40 MG Oral CapsuleSCDb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390644enzalutamide 40 MG Oral TabletSCDb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390648enzalutamide 80 MG Oral TabletSCDb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
1307309Xtandi 40 MG Oral CapsuleSYb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390646Xtandi 40 MG Oral TabletSYb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22
2390650Xtandi 80 MG Oral TabletSYb129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0469-0125-99004690125991 BOTTLE in 1 CARTON (0469-0125-99) / 120 CAPSULE in 1 BOTTLE1 bottle2012-08-310000-00-00NoNoCurrent