TOPIRAMATE (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 25 mg

NDC 62756-707-83
Topiramate Tablets
25 mg
Rx only
30 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY

topiramate-label-25 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 50 mg

NDC 62756-710-83
Topiramate Tablets
50 mg
Rx only
30 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY

topiramate-label-50 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 100 mg

NDC 62756-711-83
Topiramate Tablets
100 mg
Rx only
30 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY

topiramate-label-100 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 200 mg

NDC 62756-712-83
Topiramate Tablets
200 mg
Rx only
30 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY

topiramate-label-200 mg
(click image for full-size original)
TOPIRAMATE topiramate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-707
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
Product Characteristics
Color white Score no score
Shape ROUND (circular) Size 6mm
Flavor Imprint Code S;707
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-707-83 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:62756-707-86 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:62756-707-88 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:62756-707-08 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:62756-707-13 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:62756-707-18 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090278 03/27/2009
TOPIRAMATE topiramate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape ROUND (circular) Size 7mm
Flavor Imprint Code S;710
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-710-83 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:62756-710-86 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:62756-710-88 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:62756-710-08 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:62756-710-13 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:62756-710-18 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090278 03/27/2009
TOPIRAMATE topiramate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape ROUND (circular) Size 10mm
Flavor Imprint Code S;711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-711-83 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:62756-711-86 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:62756-711-88 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:62756-711-08 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:62756-711-13 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:62756-711-18 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090278 03/27/2009
TOPIRAMATE topiramate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-712
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
FERRIC OXIDE RED
LECITHIN, SOYBEAN
FERROSOFERRIC OXIDE
Product Characteristics
Color brown Score no score
Shape ROUND (circular) Size 12mm
Flavor Imprint Code S;712
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-712-83 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:62756-712-86 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:62756-712-88 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:62756-712-08 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:62756-712-13 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:62756-712-18 1000 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090278 03/27/2009
Labeler — Sun Pharmaceutical Industries Limited (650172430)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries 650445203 manufacture, analysis

Revised: 11/2009 Sun Pharmaceutical Industries Limited

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