FDA.reportPublic FDA data

Abiraterone

Product NDC
82009-139
11-digit product format
820090139
Labeler code
82009
Product ID
82009-139_aefba59c-022d-4f26-a6e2-ffea0ab89f26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA210686
Marketing category
ANDA
Marketing start
2019-10-07
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210686-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2019-07-10
A210686-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2024-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210686-001AB
A210686-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210686-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-07-10a50c72e98297…
2026-08-01 22:54:322026-06A210686-002ABIRATERONE ACETATE500MGTABLET / ORALAB2024-04-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210686-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A210686-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AbirateroneABIRATERONE ACETATEBluePoint Laboratories32f6b83d-c743-4934-9a20-1b5bf9f4eea32026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210686
application number: ANDA210686
AbirateroneABIRATERONE ACETATENovadoz Pharmaceuticals LLC88d05db3-8bdc-47f1-bb00-6b4a71f986092025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210686
application number: ANDA210686
AbirateroneABIRATERONE ACETATEQuallent Pharmaceuticals Health LLC6f5b628b-69da-4a04-a4d5-623b18d1fd5d2024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210686
application number: ANDA210686
ndc (product): 82009-139

Additional Listing Data#

Finished product
Yes
Brand name base
Abiraterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EM5OCB9YJ6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100075Internal RxNorm lookup
1918042Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f5b628b-69da-4a04-a4d5-623b18d1fd5dAvailable on FDA.report

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
82009-139-12Abiraterone120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-139-12EA - Each82009-13970897468-4600-45dd-aa3d-e89a590d767112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-139ABIRATERONE (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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-139-1282009013912120 TABLET in 1 BOTTLE (82009-139-12) 120 tablet2024-06-15NoNoCurrent