FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
0093-1125
Requested package NDC
0093-1125-89
11-digit product format
000931125
Labeler code
0093
Product ID
0093-1125_81772086-cab1-4658-8132-d0650a06a4c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone Acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA208432
Marketing category
ANDA
Marketing start
2018-11-21
Marketing end
0000-00-00
Substance
ABIRATERONE ACETATE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage0093-11250093-1125-89DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208432-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORAL2018-10-31

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 22:54:322026-06A208432-001ABIRATERONE ACETATE250MGTABLET / ORAL2018-10-31a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1125-89EA - Each0093-11253abf8086-3926-475a-a68c-96a7c9c17eb912018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-1125-8900093112589120 TABLET, FILM COATED in 1 BOTTLE (0093-1125-89) 2018-11-210000-00-00NoNoCurrent