FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
60687-790
11-digit product format
606870790
Labeler code
60687
Product ID
60687-790_2f0ff61e-95d0-1f19-e063-6294a90a2e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA208327
Marketing category
ANDA
Marketing start
2024-07-31
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

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
60687-790-11Abiraterone Acetate1 in 1 BLISTER PACKTABLET12
60687-790-21Abiraterone Acetate30 in 1 CARTONTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-790-11EA - Each60687-7908de8b3c8-787d-4aec-bfd4-9d3cf147db1812024-08-12
60687-790-21EA - Each60687-79091e73ad3-edd6-4a65-baa9-09adcfd3afed12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-790ABIRATERONE ACETATE (ABIRATERONE) TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250228_b36bff33-595e-4827-9a73-85c6954c314c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSNb36bff33-595e-4827-9a73-85c6954c314c2
1100075abiraterone acetate 250 MG Oral TabletSCDb36bff33-595e-4827-9a73-85c6954c314c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-790-11606870790111 in 1 BLISTER PACKHistorical
60687-790-216068707902130 BLISTER PACK in 1 CARTON (60687-790-21) / 1 TABLET in 1 BLISTER PACK (60687-790-11) 30 blister pack2024-07-31NoNoHistorical