Abiraterone Acetate

Product NDC
51407-503
11-digit product format
514070503
Labeler code
51407
Product ID
51407-503_48d6c090-b0d3-a69e-e063-6394a90ae49a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
NDA210308
Marketing category
NDA
Marketing start
2018-05-22
Substance
ABIRATERONE ACETATE
Active strength
125 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Abiraterone Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEM5OCB9YJ6
Rxcui2046579

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
51407-503-12Abiraterone Acetate120 in 1 BOTTLE, PLASTICTABLET1202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046579abiraterone acetate 125 MG Oral TabletPSN445e70a1-25bd-8fc1-e063-6394a90a1a432
2046579abiraterone acetate 125 MG Oral TabletSCD445e70a1-25bd-8fc1-e063-6394a90a1a432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-503-1251407050312120 TABLET in 1 BOTTLE, PLASTIC (51407-503-12) 120 tablet2025-09-04NoNoCurrent