FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
60219-1165
11-digit product format
602191165
Labeler code
60219
Product ID
60219-1165_7f57b4d0-9c5f-4714-830b-c7736c3d8b2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208327
Marketing category
ANDA
Marketing start
2023-04-28
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
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
ndc (product): 60219-1165
Abiraterone AcetateABIRATERONEAmneal Pharmaceuticals NY LLCc9eb9b46-f847-40a8-802c-a51b40406d5a2023-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208327
application number: ANDA208327

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 · 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
6fda6b92-59ed-4180-af68-94052a5e82cfAvailable 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
60219-1165-7Abiraterone Acetate120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1165-7EA - Each60219-116567d40414-644c-463c-a87d-d062bd005f0a12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1165ABIRATERONE ACETATE (ABIRATERONE) TABLET ABIRATERONE ACETATE (ABIRATERONE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]2Current NDC, 1 package rows20240420_6fda6b92-59ed-4180-af68-94052a5e82cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN6fda6b92-59ed-4180-af68-94052a5e82cf2
1100075abiraterone acetate 250 MG Oral TabletPSNb36bff33-595e-4827-9a73-85c6954c314c2
1918042abiraterone acetate 500 MG Oral TabletPSN6fda6b92-59ed-4180-af68-94052a5e82cf2
1100075abiraterone acetate 250 MG Oral TabletSCD6fda6b92-59ed-4180-af68-94052a5e82cf2
1100075abiraterone acetate 250 MG Oral TabletSCDb36bff33-595e-4827-9a73-85c6954c314c2
1918042abiraterone acetate 500 MG Oral TabletSCD6fda6b92-59ed-4180-af68-94052a5e82cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1165-760219116507120 TABLET in 1 BOTTLE (60219-1165-7) 120 tablet2023-04-28NoNoCurrent