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

Additional Listing Data#

Finished product
Yes
Brand name base
Abiraterone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEM5OCB9YJ6
Rxcui1918042

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e8e8aba9-b811-8b6a-ff1e-1aec10655d95Product name820240223
8f213b7a-23f6-497c-a54d-8a37f1798781Product name120231023
fb7d5d26-0d70-42a5-a005-42898b3cfc3fProduct name120180730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2151-6Abiraterone Acetate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2151-6EA - Each72162-2151d89b9907-ce1c-400d-b9b6-4cfc7f63318012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2151ABIRATERONE ACETATE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231209_79082b18-adde-4ffb-832a-b8c1d030c413.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1918042abiraterone acetate 500 MG Oral TabletPSN79082b18-adde-4ffb-832a-b8c1d030c413100
1918042abiraterone acetate 500 MG Oral TabletSCD79082b18-adde-4ffb-832a-b8c1d030c413100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2151-67216221510660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-2151-6) 2023-12-07NoNoCurrent