Zonisamide (Page 11 of 11)

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Zonisamide Capsules USP, 100mg

NDC 68001-244-00, 100 Capsules

Zonisamide 100mg
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ZONISAMIDE
zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZONISAMIDE (ZONISAMIDE) ZONISAMIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
GELATIN, UNSPECIFIED
D&C RED NO. 28
FD&C BLUE NO. 1
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BLUE (light blue cap) , WHITE (white opaque body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code G24;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-242-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077651 03/13/2014
ZONISAMIDE
zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-243
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZONISAMIDE (ZONISAMIDE) ZONISAMIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color YELLOW (yellow gold cap) , WHITE (white opaque body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code G24;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-243-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077651 03/13/2014
ZONISAMIDE
zonisamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-244
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZONISAMIDE (ZONISAMIDE) ZONISAMIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color GREEN (light green cap) , WHITE (white opaque body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G24;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-244-00 100 CAPSULE in 1 BOTTLE None
2 NDC:68001-244-03 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077651 03/13/2014
Labeler — BluePoint Laboratories (985523874)
Registrant — Glenmark Pharmaceuticals Inc (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Limited 677318665 ANALYSIS (68001-242), ANALYSIS (68001-243), ANALYSIS (68001-244), MANUFACTURE (68001-242), MANUFACTURE (68001-243), MANUFACTURE (68001-244)

Revised: 09/2020 BluePoint Laboratories

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