Temozolomide: Package Insert and Label Information (Page 5 of 5)

NDC 65162-805-51

Temozolomide Capsules USP, 180 mg

Rx only

5 Capsules

Amneal Pharmaceuticals LLC

11
(click image for full-size original)
12
(click image for full-size original)

NDC 65162-806-51
Temozolomide Capsules USP, 250 mg
Rx only
5 Capsules
Amneal Pharmaceuticals LLC

11
(click image for full-size original)
12
(click image for full-size original)

TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-801
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
SILICON DIOXIDE
ALCOHOL
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TARTARIC ACID
GELATIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
FERRIC OXIDE YELLOW
Product Characteristics
Color white (opaque) , green (opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code AMNEAL;801
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-801-51 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-801-51)
2 NDC:65162-801-14 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-801-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203691 04/03/2015
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-802
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
SILICON DIOXIDE
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TARTARIC ACID
GELATIN
TITANIUM DIOXIDE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
FD&C YELLOW NO. 6
Product Characteristics
Color yellow (opaque) , white (opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AMNEAL;802
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-802-51 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-802-51)
2 NDC:65162-802-14 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-802-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203691 04/03/2015
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-803
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMOZOLOMIDE (TEMOZOLOMIDE) TEMOZOLOMIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TARTARIC ACID
GELATIN
TITANIUM DIOXIDE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
FD&C RED NO. 3
Product Characteristics
Color white (opaque) , pink (opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AMNEAL;803
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-803-51 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-803-51)
2 NDC:65162-803-14 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-803-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203691 04/03/2015
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-804
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
SILICON DIOXIDE
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TARTARIC ACID
GELATIN
TITANIUM DIOXIDE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white (opaque) , blue (opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AMNEAL;804
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-804-51 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-804-51)
2 NDC:65162-804-14 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-804-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203691 04/03/2015
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-805
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
SILICON DIOXIDE
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TARTARIC ACID
GELATIN
TITANIUM DIOXIDE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white (opaque) , red (opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AMNEAL;805
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-805-51 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-805-51)
2 NDC:65162-805-14 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-805-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203691 04/03/2015
TEMOZOLOMIDE temozolomide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-806
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
SILICON DIOXIDE
ANHYDROUS LACTOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TARTARIC ACID
GELATIN
TITANIUM DIOXIDE
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white (opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AMNEAL;806
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-806-51 1 BOTTLE in 1 CARTON contains a BOTTLE
1 5 CAPSULE in 1 BOTTLE This package is contained within the CARTON (65162-806-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203691 04/03/2015
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 analysis (65162-801), analysis (65162-802), analysis (65162-803), analysis (65162-804), analysis (65162-805), analysis (65162-806), label (65162-801), label (65162-802), label (65162-803), label (65162-804), label (65162-805), label (65162-806), manufacture (65162-801), manufacture (65162-802), manufacture (65162-803), manufacture (65162-804), manufacture (65162-805), manufacture (65162-806), pack (65162-801), pack (65162-802), pack (65162-803), pack (65162-804), pack (65162-805), pack (65162-806)

Revised: 01/2022 Amneal Pharmaceuticals LLC

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