FDA.reportPublic FDA data

Abiraterone

Product NDC
72205-285
11-digit product format
722050285
Labeler code
72205
Product ID
72205-285_a87a3fa5-28cb-42be-9039-af800a7c482c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA210686
Marketing category
ANDA
Marketing start
2024-04-24
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE500 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
8f213b7a-23f6-497c-a54d-8a37f1798781Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fb7d5d26-0d70-42a5-a005-42898b3cfc3fProduct name120180730
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-285-05Abiraterone500 in 1 BOTTLETABLET, FILM COATED5005
72205-285-60Abiraterone60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-285-60EA - Each72205-285a94a9fd2-d271-4465-9523-196a3515def412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-285ABIRATERONE (ABIRATERONE ACETATE) TABLET ABIRATERONE (ABIRATERONE ACETATE) TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]4Current NDC, 2 package rows20240525_88d05db3-8bdc-47f1-bb00-6b4a71f98609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN88d05db3-8bdc-47f1-bb00-6b4a71f986095
1918042abiraterone acetate 500 MG Oral TabletPSN88d05db3-8bdc-47f1-bb00-6b4a71f986095
1100075abiraterone acetate 250 MG Oral TabletSCD88d05db3-8bdc-47f1-bb00-6b4a71f986095
1918042abiraterone acetate 500 MG Oral TabletSCD88d05db3-8bdc-47f1-bb00-6b4a71f986095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-285-0572205028505500 TABLET, FILM COATED in 1 BOTTLE (72205-285-05) 2024-05-24NoNoCurrent
72205-285-607220502856060 TABLET, FILM COATED in 1 BOTTLE (72205-285-60) 2024-05-24NoNoCurrent