FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
69238-1165
11-digit product format
692381165
Labeler code
69238
Product ID
69238-1165_c03e6ebe-681b-40c0-b123-741dd35fd558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208327
Marketing category
ANDA
Marketing start
2019-01-07
Substance
ABIRATERONE ACETATE
Active strength
250 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 ACETATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEM5OCB9YJ6
Rxcui1100075, 1918042

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
69238-1165-7Abiraterone Acetate120 in 1 BOTTLETABLET12032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1165-7EA - Each69238-11650c918b12-0af8-4ce3-b6bf-e0464036057b12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1165ABIRATERONE ACETATE (ABIRATERONE) TABLET ABIRATERONE ACETATE (ABIRATERONE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]32Current NDC, Legacy NDC, 1 package rows20231128_c9eb9b46-f847-40a8-802c-a51b40406d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSNc9eb9b46-f847-40a8-802c-a51b40406d5a32
1918042abiraterone acetate 500 MG Oral TabletPSNc9eb9b46-f847-40a8-802c-a51b40406d5a32
1100075abiraterone acetate 250 MG Oral TabletSCDc9eb9b46-f847-40a8-802c-a51b40406d5a32
1918042abiraterone acetate 500 MG Oral TabletSCDc9eb9b46-f847-40a8-802c-a51b40406d5a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1165-769238116507120 TABLET in 1 BOTTLE (69238-1165-7) 120 tablet2019-01-070000-00-00NoNoCurrent