ntains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0085-1430-01 1 BOTTLE, GLASS 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 NDC:0085-1430-02 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1430-02)
3 NDC:0085-1430-03 5 PACKET in 1 CARTON contains a PACKET (0085-1430-05)
3 NDC:0085-1430-05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-1430-03)
4 NDC:0085-1430-04 14 PACKET in 1 CARTON contains a PACKET (0085-1430-05)
4 NDC:0085-1430-05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-1430-04)
Mrketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021029 08/11/1999
TEMODAR temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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 154.3 mg
silicon dioxide 0.7 mg
sodium starch glycolate type A potato 22.5 mg
tartaric acid 9 mg
stearic acid 13.5 mg
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
# Item Code Package Description Multilevel Packaging
1 NDC:0085-1417-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1417-01)
2 NDC:0085-1417-02 5 PACKET in 1 CARTON contains a PACKET (0085-1417-03)
2 NDC:0085-1417-03 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-1417-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021029 08/11/1999
TEMODAR temozolomide injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-1381
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide) Temozolomide 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
mannitol 15 mg in 1 mL
threonine 4 mg in 1 mL
polysorbate 80 3 mg in 1 mL
trisodium citrate dihydrate 5.9 mg in 1 mL
hydrochloric acid 4 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0085-1381-01 1 VIAL, SINGLE-USE in 1 CAR |
