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NDC 71921-0177-06 Abiraterone acetate 500 mg/1 Details

Abiraterone acetate 500 mg/1

Abiraterone acetate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Florida Pharmaceutical Products, LLC. The primary component is ABIRATERONE ACETATE.

MedlinePlus Drug Summary

Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.

Related Packages: 71921-0177-06
Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Abiraterone

Product Information

NDC	71921-0177
Product ID	71921-177_f8b632d6-dbe5-e56a-e053-6394a90a3597
Associated GPIs
GCN Sequence Number	077249
GCN Sequence Number Description	abiraterone acetate TABLET 500 MG ORAL
HIC3	V1J
HIC3 Description	ANTINEOPLASTIC - ANTIANDROGENIC AGENTS
GCN	43205
HICL Sequence Number	037571
HICL Sequence Number Description	ABIRATERONE ACETATE
Brand/Generic	Generic
Proprietary Name	Abiraterone acetate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Abiraterone acetate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ABIRATERONE ACETATE
Labeler Name	Florida Pharmaceutical Products, LLC
Pharmaceutical Class	Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA215086
Listing Certified Through	2024-12-31

Package

NDC 71921-0177-06 (71921017706)

Pricing Information	N/A
NDC Package Code	71921-177-06
Billing NDC	71921017706
Package	60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06)
Marketing Start Date	2023-04-10
NDC Exclude Flag	N