t summarizes the most important information about ZYTIGA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZYTIGA that is written for healthcare professionals.
For more information contact Janssen Biotech, Inc. at 1-800-457-6399 or www.Zytiga.com.
What are the ingredients of ZYTIGA?
Active ingredient: abiraterone acetate
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate and colloidal silicon dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Patheon Inc.
Mississauga, Canada
Manufactured for:
Janssen Biotech, Inc.
Horsham, PA 19044
Issued: December 2011
PRINCIPAL DISPLAY PANEL - 250 mg Bottle Label
120 TABLETS
NDC 57894-150-12
Zytiga®
(abiraterone acetate)
tablets
250 mg
Each tablet contains:
abiraterone acetate 250 mg
Warning: Women who are or may be
pregnant should not handle ZYTIGA
without gloves (see package insert).
janssen
ZYTIGA
abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
abiraterone acetate (abiraterone) abiraterone acetate 250 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
croscarmellose sodium
povidone
sodium lauryl sulfate
magnesium stearate
silicon dioxide
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code AA250
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:57894-150-12 120 TABLET ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202379 04/28/2011
Labeler - Janssen Biotech, Inc. (099091753)
Establishment
Name Address ID/FEI Operations
Cambridge Major Laboratories 054452136 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Cambridge Major Laboratories 961717936 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Patheon, Inc. 240769596 MANUFACTURE, ANALYSIS, PACK
Establishment
Name Address ID/FEI Operations
Patheon, Inc. 259484350 ANALYSIS
Revised: 12/2011 Janssen Biotech, Inc.
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