Abiraterone Acetate

Product NDC
72162-2151
11-digit product format
721622151
Labeler code
72162
Product ID
72162-2151_2d3f3959-77b9-418f-9e9a-eccb0501dadf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208446
Marketing category
ANDA
Marketing start
2020-12-14
Substance
ABIRATERONE ACETATE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
EM5OCB9YJ6ABIRATERONE ACETATE154229-18-2ABIRATERONE ACETATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2151-67216221510660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-2151-6) 2023-12-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Abiraterone AcetateBryant Ranch Prepack2023-12-07HUMAN PRESCRIPTION DRUG LABEL100