FDA.reportPublic FDA data

Zytiga

Product NDC
57894-195
11-digit product format
578940195
Labeler code
57894
Product ID
57894-195_316974bf-2b6d-9d66-e063-6294a90a33a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Biotech, Inc.
Application
NDA202379
Marketing category
NDA
Marketing start
2017-04-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zytiga
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEM5OCB9YJ6
Rxcui1100075, 1100079, 1918042, 1918044

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
57894-195-06Zytiga60 in 1 BOTTLETABLET, FILM COATED6040
57894-195-15Zytiga60 in 1 BOTTLETABLET, FILM COATED6040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-195-06EA - Each57894-195fc6daf97-7b49-48b3-a39c-2e52ebd793d312017-06-15

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
57894-195ZYTIGA (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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-195-065789401950660 TABLET, FILM COATED in 1 BOTTLE (57894-195-06) 2017-04-170000-00-00NoNoCurrent
57894-195-155789401951560 TABLET, FILM COATED in 1 BOTTLE (57894-195-15) 2017-04-170000-00-00YesNoCurrent