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NDC 62559-0680-30 CASODEX 50 mg/1 Details

CASODEX 50 mg/1

CASODEX is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, 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: 62559-0680-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bicalutamide

Product Information

NDC	62559-0680
Product ID	62559-680_88aa17b6-89ad-4441-a72f-2fb3ce49de1a
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	Brand
Proprietary Name	CASODEX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bicalutamide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	BICALUTAMIDE
Labeler Name	ANI Pharmaceuticals, Inc.
Pharmaceutical Class	Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020498
Listing Certified Through	2024-12-31

Package

NDC 62559-0680-30 (62559068030)

Pricing Information	N/A
NDC Package Code	62559-680-30
Billing NDC	62559068030
Package	30 TABLET in 1 BOTTLE (62559-680-30)
Marketing Start Date	2018-06-26
NDC Exclude Flag	N