FDA.reportPublic FDA data

abiraterone acetate

Product NDC
71921-178
11-digit product format
719210178
Labeler code
71921
Product ID
71921-178_38b4b689-c306-42a0-9df6-5b125314aaab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC.
Application
ANDA212462
Marketing category
ANDA
Marketing start
2022-08-15
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
A212462-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2019-09-27
A212462-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2021-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212462-001AB
A212462-002AB

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 22:54:322026-06A212462-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-09-27a50c72e98297…
2026-08-01 22:54:322026-06A212462-002ABIRATERONE ACETATE500MGTABLET / ORALAB2021-06-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212462-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212462-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
abiraterone acetateABIRATERONE ACETATEApotex Corp.9ce9d926-ef3a-4b22-a703-f49c18eb4e3d2023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212462
application number: ANDA212462
abiraterone acetateABIRATERONE ACETATEFlorida Pharmaceutical Products, LLC.b3e7f851-4132-4003-8f14-0eea21e5009c2023-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212462
application number: ANDA212462
ndc (product): 71921-178

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
b3e7f851-4132-4003-8f14-0eea21e5009cAvailable 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
71921-178-20abiraterone acetate120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-178-20EA - Each71921-178553b3bac-de07-445d-a737-ca48625d07bc12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-178ABIRATERONE ACETATE TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC.]2Current NDC, Legacy NDC, 1 package rows20230429_b3e7f851-4132-4003-8f14-0eea21e5009c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSNb3e7f851-4132-4003-8f14-0eea21e5009c2
1100075abiraterone acetate 250 MG Oral TabletSCDb3e7f851-4132-4003-8f14-0eea21e5009c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71921-178-2071921017820120 TABLET in 1 BOTTLE (71921-178-20) 120 tablet2022-08-150000-00-00NoNoCurrent