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) 0085-1417
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide) Temozolomide 250 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
sodium lauryl sulfate
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code TEMODAR;250;mg
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1417-01 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE In 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1417-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021029 02/27/2010
TEMODAR
temozolomide injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-1381
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide) Temozolomide 100 mg in 40 mL
Inactive Ingredients
Ingredient Name Strength
mannitol
threonine
polysorbate 80
trisodium citrate dihydrate
hydrochloric acid
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0085-1381-01 1 VIAL In 1 CARTON contains a VIAL, SINGLE-USE
1 40 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (0085-1381-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022277 02/27/2010
Labeler - Schering Corporation (001317601)
Establishment
Name Address ID/FEI Operations
SCHERING PLOUGH PRODUCTS LLC 967869058 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Baxter Oncology GMBH 344276063 MANUFACTURE
Establishment
Name Address ID/FEI Operations
SCHERING
