05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-1366-04)
Marketing 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:0085-1425
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 246 mg
silicon dioxide 0.4 mg
sodium starch glycolate type A potato 21 mg
tartaric acid 4.2 mg
stearic acid 8.4 mg
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
Item Code Package Description Multilevel Packaging
1 NDC:0085-1425-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1425-01)
2 NDC:0085-1425-02 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1425-02)
3 NDC:0085-1425-03 5 PACKET in 1 CARTON contains a PACKET (0085-1425-05)
3 NDC:0085-1425-05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-1425-03)
4 NDC:0085-1425-04 14 PACKET in 1 CARTON contains a PACKET (0085-1425-05)
4 NDC:0085-1425-05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-1425-04)
Marketing 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:0085-1430
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 316.3 mg
silicon dioxide 0.5 mg
sodium starch glycolate type A potato 27 mg
tartaric acid 5.4 mg
stearic acid 10.8 mg
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
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