For Oral Administration
Rx only

THIS PACKAGE CONTAINS
5 CAPSULES
PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

NDC 0085-1519-02

20 mg
per capsule

Temodar®
(temozolomide)
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS
5 CAPSULES
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Carton

NDC 0085-1366-02

100 mg
per capsule

Temodar®
(temozolomide)
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS
5 CAPSULES

PRINCIPAL DISPLAY PANEL - 140 mg Capsule Bottle Carton

NDC 0085-1425-01

140 mg
per capsule

Temodar®
(temozolomide)
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS
5 CAPSULES
PRINCIPAL DISPLAY PANEL - 180 mg Capsule Bottle Carton

NDC 0085-1430-01

180 mg
per capsule

Temodar®
(temozolomide)
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS
5 CAPSULES
PRINCIPAL DISPLAY PANEL - 250 mg Capsule Bottle Carton

NDC 0085-1417-01

250 mg
per capsule

Temodar®
(temozolomide)
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS
5 CAPSULES
PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton

NDC 0085-1381-01

Temodar®
[temozolomide]
for Injection

100 mg/VIAL

For Intravenous Use Only

Single-Use Vial.
Discard after use.

Rx only
TEMODAR 
temozolomide   capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-3004
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide)  Temozolomide 5 mg
 
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose  
silicon dioxide  
sodium starch glycolate type A potato  
tartaric acid  
stearic acid  
shellac  
alcohol  
isopropyl alcohol  
butyl alcohol  
propylene glycol  
water  
ammonia  
potassium hydroxide  
ferric oxide red  
gelatin  
titanium dioxide  
ferric oxide yellow  
sodium lauryl sulfate  
FD&C Blue No. 2  
 
Product Characteristics
Color GREEN, WHITE Score no score 
Shape CAPSULE Size 16mm
Flavor  Imprint Code TEMODAR;5;mg 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0085-3004-02 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
1  5 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-3004-02)
2 0085-3004-01 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
2  14 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-3004-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021029 02/27/2010 

TEMODAR 
temozolomide   capsule
Product Information
Pr