x only
THIS PACKAGE CONTAINS5 CAPSULES
(click image for full-size original) 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 CONTAINS5 CAPSULES
(click image for full-size original) 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 CONTAINS5 CAPSULES
(click image for full-size original) 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
(click image for full-size original) TEMODAR temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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 132.8 mg
silicon dioxide 0.2 mg
sodium starch glycolate type A potato 7.5 mg
tartaric acid 1.5 mg
stearic acid 3 mg
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
Item Code Package Description Multilevel Packaging
1 NDC:0085-3004-02 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 5 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-3004-02)
2 NDC:0085-3004-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
2 14 CAPSULE in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-3004-01)
3 NDC:0085-3004-03 5 PACKET in 1 CARTON contains a PACKET (0085-3004-05)
3 NDC:0085-3004-05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-3004-03)
4 NDC:0085-3004-04 14 PACKET in 1 CARTON contains a PACKET (0085-3004-05)
4 NDC:0085-3004-05 1 CAPSULE in 1 PACKET This package is contained within the CARTON (0085-3004-04)
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:0085-1519
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Temozolomide (Temozolomide) Temozolomide 20 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose 182.2 mg
silicon dioxide 0.2 mg
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