FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
75907-224
11-digit product format
759070224
Labeler code
75907
Product ID
75907-224_6c96e35d-9099-e164-0960-353b01420f81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA208416
Marketing category
ANDA
Marketing start
2025-03-17
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
A208416-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2020-05-18
A208416-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2023-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208416-001AB
A208416-002AB

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 22:54:322026-06A208416-001ABIRATERONE ACETATE250MGTABLET / ORALAB2020-05-18a50c72e98297…
2026-08-01 22:54:322026-06A208416-002ABIRATERONE ACETATE500MGTABLET / ORALAB2023-09-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208416-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208416-002AB1a50c72e98297…

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 AcetateABIRATERONE ACETATEAvPAK5108c2fe-9706-c976-e063-6294a90a796d2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208416
application number: ANDA208416
Abiraterone AcetateABIRATERONE ACETATEDr. Reddys Laboratories Inc0c91aa38-3b0a-232c-8eb1-55f08e8e66442025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208416
application number: ANDA208416
ndc (product): 75907-224
Abiraterone AcetateABIRATERONE ACETATENorthStar Rx LLC39434b24-bf64-f5c9-fbb6-b0d2250994242023-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208416
application number: ANDA208416
Abiraterone AcetateABIRATERONE ACETATEDr. Reddys Laboratories Inc7eda0d98-c2ba-c117-b757-1f566292e7892023-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208416
application number: ANDA208416

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
0c91aa38-3b0a-232c-8eb1-55f08e8e6644Available 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
75907-224-04Abiraterone Acetate120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-224-04EA - Each75907-2245f47ccba-49c4-4791-8920-664571c645dd12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-224ABIRATERONE ACETATE TABLET [DR. REDDYS LABORATORIES INC]1Current NDC, 1 package rows20250327_0c91aa38-3b0a-232c-8eb1-55f08e8e6644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN0c91aa38-3b0a-232c-8eb1-55f08e8e66441
1100075abiraterone acetate 250 MG Oral TabletSCD0c91aa38-3b0a-232c-8eb1-55f08e8e66441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-224-0475907022404120 TABLET in 1 BOTTLE (75907-224-04) 120 tablet2025-03-17NoNoCurrent