TEMODAR 
temozolomide   capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1425
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide)  Temozolomide 140 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  
sodium lauryl sulfate  
FD&C Blue No. 2  
 
Product Characteristics
Color BLUE, WHITE Score no score 
Shape CAPSULE Size 20mm
Flavor  Imprint Code TEMODAR;140;mg 
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1425-01 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
1  5 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1425-01)
2 0085-1425-02 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
2  14 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1425-02)
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
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1430
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide)  Temozolomide 180 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  
ferric oxide yellow  
titanium dioxide  
sodium lauryl sulfate  
 
Product Characteristics
Color ORANGE, WHITE Score no score 
Shape CAPSULE Size 20mm
Flavor  Imprint Code TEMODAR;180;mg 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1430-01 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
1  5 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1430-01)
2 0085-1430-02 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
2  14 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1430-02)