FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
63629-9430
Requested package NDC
63629-9430-1
11-digit product format
636299430
Labeler code
63629
Product ID
63629-9430_69a2c18e-f623-43fd-bd10-ed154dcc5b9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215947
Marketing category
ANDA
Marketing start
2022-01-05
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-943063629-9430-1DDiscontinued by firm2026-08-03

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9430-1EA - Each63629-94304745e38b-9eae-4215-a7e5-644b97e85d6612022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9430-16362994300160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9430-1) 2022-08-230000-00-00NoNoCurrent