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NDC 47335-0485-08 bicalutamide 50 mg/1 Details

bicalutamide 50 mg/1

bicalutamide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is BICALUTAMIDE.

MedlinePlus Drug Summary

Bicalutamide is used with another medication (gonadotropin-releasing hormone (GnRH) agonists; such as leuprolide or goserelin) to treat metastatic prostate cancer (cancer that started in the prostate and has spread to other parts of the body). Bicalutamide is in a class of medications called nonsteroidal antiandrogens. It works by blocking the effect of androgen (a male hormone), to stop the growth and spread of cancer cells.

Related Packages: 47335-0485-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bicalutamide

Product Information

NDC	47335-0485
Product ID	47335-485_03950328-e671-448e-af60-14af3c9725f0
Associated GPIs	21402420000320
GCN Sequence Number	024153
GCN Sequence Number Description	bicalutamide TABLET 50 MG ORAL
HIC3	V1J
HIC3 Description	ANTINEOPLASTIC - ANTIANDROGENIC AGENTS
GCN	00450
HICL Sequence Number	010143
HICL Sequence Number Description	BICALUTAMIDE
Brand/Generic	Generic
Proprietary Name	bicalutamide
Proprietary Name Suffix	n/a
Non-Proprietary Name	bicalutamide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	BICALUTAMIDE
Labeler Name	Sun Pharmaceutical Industries, Inc.
Pharmaceutical Class	Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA079110
Listing Certified Through	2024-12-31

Package

NDC 47335-0485-08 (47335048508)

Pricing Information	N/A
NDC Package Code	47335-485-08
Billing NDC	47335048508
Package	100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)
Marketing Start Date	2014-12-15
NDC Exclude Flag	N