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NDC 00469-1125-56 Xtandi 40 mg/1 Details

Xtandi 40 mg/1

Xtandi is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Astellas Pharma US, Inc.. The primary component is ENZALUTAMIDE.

MedlinePlus Drug Summary

Enzalutamide is used to treat prostate cancer that has spread to other parts of the body in men and who have been helped by certain medical and surgical treatments that decrease testosterone levels. It is also used to treat prostate cancer in men who have not been helped by certain medical and surgical treatments that decrease testosterone levels. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

Related Packages: 00469-1125-56
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Enzalutamide

Product Information

NDC	00469-1125
Product ID	0469-1125_bddcc9f9-afad-4b83-a6d7-551f3cfd9cdb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Xtandi
Proprietary Name Suffix	n/a
Non-Proprietary Name	enzalutamide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	40
Active Ingredient Units	mg/1
Substance Name	ENZALUTAMIDE
Labeler Name	Astellas Pharma US, Inc.
Pharmaceutical Class	Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA203415
Listing Certified Through	2024-12-31

Package

NDC 00469-1125-56 (00469112556)

Pricing Information	N/A
NDC Package Code	0469-1125-56
Billing NDC	00469112556
Package	56 CAPSULE in 1 BLISTER PACK (0469-1125-56)
Marketing Start Date	2012-08-31
NDC Exclude Flag	N