Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ZOLINZA for a condition for which it was not prescribed. Do not give ZOLINZA to other people, even if they have the same symptoms you have. It may harm them.
Keep ZOLINZA and all medicines out of the reach of children.

This leaflet summarizes the most important information about ZOLINZA. If you would like to know more information, talk to your doctor. You can ask your doctor or pharmacist for information about ZOLINZA that is written for health professionals.
What are the ingredients in ZOLINZA?

Active ingredient: vorinostat

Inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The inactive ingredients in the capsule shell are titanium dioxide, gelatin, and sodium lauryl sulfate.

How should I store ZOLINZA?

Store ZOLINZA at room temperature, 68°F-77°F (20°C-25°C).
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
Patheon, Inc.
Mississauga, Ontario, Canada L5N 7K9

U.S. Patent Nos. RE 38,506 E; 6,087,367

Copyright © 2006, 2009, 2011, 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 04/2013

USPPI-C-0683-1304R006

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

NDC 0006-0568-40

Zolinza®
(vorinostat) capsules

100 mg

Direct contact of the powder in ZOLINZA
capsules with the skin or mucous
membranes should be avoided.
(See Package Insert.)

Rx only

120 Capsules

568
100 mg

ZOLINZA 
vorinostat capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-0568
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORINOSTAT (VORINOSTAT)  VORINOSTAT 100 mg
 
Inactive Ingredients
Ingredient Name Strength
GELATIN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
 
Product Characteristics
Color WHITE (white, opaque)  Score no score
Shape CAPSULE (CAPSULE)  Size 16mm
Flavor  Imprint Code 568;100;mg 
Contains     
 
Packaging
# Item Code Package Description
1 NDC:0006-0568-40 120 in 1 BOTTLE
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021991 10/06/2006 
 
Labeler - Merck Sharp & Dohme Corp. (001317601) 
Establishment
Name Address ID/FEI Business Operations
Patheon Inc.  240769596 MANUFACTURE(0006-0568)
Establishment
Name Address ID/FEI Business Operations
AMRI Rensselaer, Inc.  124193793 API MANUFACTURE(0006-0568)
Establishment
Name Address ID/FEI Business Operations
Merck Sharp & Dohme Corp.  101740835 PACK(0006-0568)