FDA.reportPublic FDA data

Abiraterone

Product NDC
82009-140
11-digit product format
820090140
Labeler code
82009
Product ID
82009-140_aefba59c-022d-4f26-a6e2-ffea0ab89f26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA210686
Marketing category
ANDA
Marketing start
2019-10-07
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
82009-140-60Abiraterone60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-140-60EA - Each82009-140cd5fe8c7-8a6f-40ee-b979-ee4e213ec0c812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-140ABIRATERONE (ABIRATERONE ACETATE) TABLET ABIRATERONE (ABIRATERONE ACETATE) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]2Current NDC, 1 package rows20240723_6f5b628b-69da-4a04-a4d5-623b18d1fd5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN6f5b628b-69da-4a04-a4d5-623b18d1fd5d2
1918042abiraterone acetate 500 MG Oral TabletPSN6f5b628b-69da-4a04-a4d5-623b18d1fd5d2
1100075abiraterone acetate 250 MG Oral TabletSCD6f5b628b-69da-4a04-a4d5-623b18d1fd5d2
1918042abiraterone acetate 500 MG Oral TabletSCD6f5b628b-69da-4a04-a4d5-623b18d1fd5d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82009-140-608200901406060 TABLET, FILM COATED in 1 BOTTLE (82009-140-60) 2024-07-16NoNoCurrent