FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
60505-4327
11-digit product format
605054327
Labeler code
60505
Product ID
60505-4327_0eeb49ee-ae24-1cac-cf45-7b6064981875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA208453
Marketing category
ANDA
Marketing start
2018-11-23
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-432760505-4327-3DDiscontinued by firm2026-07-31

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208453-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208453-001AB

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 22:54:322026-06A208453-001ABIRATERONE ACETATE250MGTABLET / ORALAB2018-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208453-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abiraterone AcetateABIRATERONE ACETATEMajor Pharmaceuticals49809a29-6558-43a3-a347-5027de44aa412026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208453
application number: ANDA208453
Abiraterone AcetateABIRATERONE ACETATEApotex Corp.2ac063f0-4177-c90f-27c3-e70e296892552025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208453
application number: ANDA208453
ndc (product): 60505-4327

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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ac063f0-4177-c90f-27c3-e70e29689255Available on FDA.report

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
60505-4327-1Abiraterone Acetate120 in 1 BOTTLETABLET12010
60505-4327-3Abiraterone Acetate360 in 1 BOTTLETABLET36010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4327-1EA - Each60505-4327dab732de-d86a-4c80-b693-e1791eedf6eb12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4327ABIRATERONE ACETATE TABLET [APOTEX CORP.]9Current NDC, Legacy NDC, 2 package rows20240919_2ac063f0-4177-c90f-27c3-e70e29689255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN2ac063f0-4177-c90f-27c3-e70e2968925510
1100075abiraterone acetate 250 MG Oral TabletSCD2ac063f0-4177-c90f-27c3-e70e2968925510
1100075abiraterone acetate 250 MG Oral TabletPSN49809a29-6558-43a3-a347-5027de44aa415
1100075abiraterone acetate 250 MG Oral TabletSCD49809a29-6558-43a3-a347-5027de44aa415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4327-160505432701120 TABLET in 1 BOTTLE (60505-4327-1) 120 tablet2018-11-230000-00-00NoNoCurrent
60505-4327-360505432703360 TABLET in 1 BOTTLE (60505-4327-3) 360 tablet2018-11-230000-00-00NoNoCurrent