FDA.reportPublic FDA data

ABIRATERONE ACETATE

Product NDC
42291-073
11-digit product format
422910073
Labeler code
42291
Product ID
42291-073_ec19a5c9-a06e-4082-e053-2995a90aba71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ABIRATERONE
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA208327
Marketing category
ANDA
Marketing start
2021-04-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-073DDiscontinued by firm2026-07-31
excluded packagepackage42291-07342291-073-60DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208327-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2019-01-07
A208327-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2020-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208327-001AB
A208327-002AB

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 22:54:322026-06A208327-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-01-07a50c72e98297…
2026-08-01 22:54:322026-06A208327-002ABIRATERONE ACETATE500MGTABLET / ORALAB2020-12-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208327-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208327-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abiraterone AcetateABIRATERONEAvKARE7f82d549-6654-1efd-e053-2991aa0aa28d2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208327
application number: ANDA208327
Abiraterone AcetateABIRATERONEAmerican Health Packagingb36bff33-595e-4827-9a73-85c6954c314c2025-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208327
application number: ANDA208327
Abiraterone AcetateABIRATERONEAmneal Pharmaceuticals NY LLC6fda6b92-59ed-4180-af68-94052a5e82cf2023-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208327
application number: ANDA208327
Abiraterone AcetateABIRATERONEAmneal Pharmaceuticals NY LLCc9eb9b46-f847-40a8-802c-a51b40406d5a2023-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208327
application number: ANDA208327

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-073-60EA - Each42291-0731f0dbb44-9fee-4dd9-98ef-6fba68a4546b12021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-073-604229100736060 TABLET in 1 BOTTLE (42291-073-60) 60 tablet2021-04-290000-00-00NoNoCurrent