FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
82293-002
11-digit product format
822930002
Labeler code
82293
Product ID
82293-002_47d0b34a-b255-d3a9-e063-6294a90aadb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novugen Pharma (USA) LLC
Application
ANDA215947
Marketing category
ANDA
Marketing start
2022-01-05
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
2027-12-31
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
A215947-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2022-01-05
A215947-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2022-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215947-001AB
A215947-002AB

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 22:54:322026-06A215947-001ABIRATERONE ACETATE250MGTABLET / ORALAB2022-01-05a50c72e98297…
2026-08-01 22:54:322026-06A215947-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-01-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215947-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A215947-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abiraterone AcetateABIRATERONE ACETATENovugen Pharma (USA) LLCf308b463-27e4-422a-95a2-ecbbf95eee202026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215947
application number: ANDA215947
ndc (product): 82293-002

Additional Listing Data#

Finished product
Yes
Brand name base
Abiraterone Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE500 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
f308b463-27e4-422a-95a2-ecbbf95eee20Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e8e8aba9-b811-8b6a-ff1e-1aec10655d95Product name820240223
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
8f213b7a-23f6-497c-a54d-8a37f1798781Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fb7d5d26-0d70-42a5-a005-42898b3cfc3fProduct name120180730
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82293-002-10Abiraterone Acetate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-002-10EA - Each82293-002201bd845-8c2f-4a90-8a24-cb442dcb4cbb12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-002ABIRATERONE ACETATE TABLET, FILM COATED [NOVUGEN PHARMA (USA) LLC]4Current NDC, Legacy NDC, 1 package rows20250201_f308b463-27e4-422a-95a2-ecbbf95eee20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSNf308b463-27e4-422a-95a2-ecbbf95eee205
1918042abiraterone acetate 500 MG Oral TabletPSNf308b463-27e4-422a-95a2-ecbbf95eee205
1100075abiraterone acetate 250 MG Oral TabletSCDf308b463-27e4-422a-95a2-ecbbf95eee205
1918042abiraterone acetate 500 MG Oral TabletSCDf308b463-27e4-422a-95a2-ecbbf95eee205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82293-002-108229300021060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82293-002-10) 2022-01-050000-00-00NoNoCurrent