FDA.reportPublic FDA data

Zytiga

Product NDC
57894-150
11-digit product format
578940150
Labeler code
57894
Product ID
57894-150_316974bf-2b6d-9d66-e063-6294a90a33a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Janssen Biotech, Inc.
Application
NDA202379
Marketing category
NDA
Marketing start
2011-04-28
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

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 packagepackage57894-15057894-150-25DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202379-001ZYTIGAABIRATERONE ACETATE250MGTABLET / ORALABRLD2011-04-28
N202379-002ZYTIGAABIRATERONE ACETATE500MGTABLET / ORALABRLD, RS2017-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N202379-001AB
N202379-002AB

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 22:54:322026-06N202379-001ZYTIGA250MGTABLET / ORALABRLD2011-04-28a50c72e98297…
2026-08-01 22:54:322026-06N202379-002ZYTIGA500MGTABLET / ORALABRLD, RS2017-04-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N202379-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N202379-002AB1a50c72e98297…

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
ZytigaABIRATERONE ACETATEJanssen Biotech, Inc.4e338e89-3cf2-48eb-b6e2-a06c608c65132025-03-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 202379
application number: NDA202379
ndc (product): 57894-150

Additional Listing Data#

Finished product
Yes
Brand name base
Zytiga
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100075Internal RxNorm lookup
1100079Internal RxNorm lookup
1918042Internal RxNorm lookup
1918044Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e338e89-3cf2-48eb-b6e2-a06c608c6513Available 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
57894-150-12Zytiga120 in 1 BOTTLETABLET12040
57894-150-25Zytiga120 in 1 BOTTLETABLET12040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-150-12EA - Each57894-1501c8d5038-cf84-4a8d-9081-959bfffcf30c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
abiraterone acetateACTIVE INGREDIENTEM5OCB9YJ6ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
abirateroneACTIVE MOIETYG819A456D0ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
magnesium stearateINACTIVE INGREDIENT70097M6I30ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
povidonesINACTIVE INGREDIENTFZ989GH94EZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JZYTIGA (ABIRATERONE ACETATE) TABLET [JANSSEN BIOTECH, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-150ZYTIGA (ABIRATERONE ACETATE) TABLET ZYTIGA (ABIRATERONE ACETATE) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]40Current NDC, Legacy NDC, 2 package rows20250331_4e338e89-3cf2-48eb-b6e2-a06c608c6513.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN4e338e89-3cf2-48eb-b6e2-a06c608c651340
1918042abiraterone acetate 500 MG Oral TabletPSN4e338e89-3cf2-48eb-b6e2-a06c608c651340
1100079Zytiga 250 MG Oral TabletPSN4e338e89-3cf2-48eb-b6e2-a06c608c651340
1918044Zytiga 500 MG Oral TabletPSN4e338e89-3cf2-48eb-b6e2-a06c608c651340
1100079abiraterone acetate 250 MG Oral Tablet [Zytiga]SBD4e338e89-3cf2-48eb-b6e2-a06c608c651340
1918044abiraterone acetate 500 MG Oral Tablet [Zytiga]SBD4e338e89-3cf2-48eb-b6e2-a06c608c651340
1100075abiraterone acetate 250 MG Oral TabletSCD4e338e89-3cf2-48eb-b6e2-a06c608c651340
1918042abiraterone acetate 500 MG Oral TabletSCD4e338e89-3cf2-48eb-b6e2-a06c608c651340
1100079Zytiga 250 MG Oral TabletSY4e338e89-3cf2-48eb-b6e2-a06c608c651340
1918044Zytiga 500 MG Oral TabletSY4e338e89-3cf2-48eb-b6e2-a06c608c651340

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57894-150-1257894015012120 TABLET in 1 BOTTLE (57894-150-12) 120 tablet2011-04-280000-00-00NoNoCurrent
57894-150-2557894015025120 in 1 BOTTLEHistorical