n Guide to each patient.
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]
Do not use if printed safety seal under cap is broken or missing.
Each tablet contains 200 mg ezogabine.
See prescribing information for dosage information.
POTIGA is a trademark of Valeant Pharmaceuticals North America.
GlaxoSmithKline, Research Triangle Park, NC 27709
Rev. 3/12
A081778
Principal Display Panel
NDC 0173-0813-59
Potiga™
(ezogabine) Tablets
300 mg
Rx only
CV
90 Tablets
Dispense the accompanying Medication Guide to each patient.
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]
Do not use if printed safety seal under cap is broken or missing.
Each tablet contains 300 mg ezogabine.
See prescribing information for dosage information.
POTIGA is a trademark of Valeant Pharmaceuticals North America.
GlaxoSmithKline, Research Triangle Park, NC 27709
Rev. 3/12
A081779
Principal Display Panel
NDC 0173-0814-59
Potiga™
(ezogabine) Tablets
400 mg
Rx only
CV
90 Tablets
Dispense the accompanying Medication Guide to each patient.
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]
Do not use if printed safety seal under cap is broken or missing.
Each tablet contains 400 mg ezogabine.
See prescribing information for dosage information.
POTIGA is a trademark of Valeant Pharmaceuticals North America.
GlaxoSmithKline, Research Triangle Park, NC 27709
Rev. 3/12
A081780
POTIGA
ezogabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZOGABINE (EZOGABINE) EZOGABINE 50 mg
Inactive Ingredients
Ingredient Name Strength
COCHINEAL
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RTG;50
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:0173-0810-59 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0173-0810-62 2 BOTTLE in 1 CARTON contains a BOTTLE (0173-0810-01)
2 NDC:0173-0810-01 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0173-0810-62)
3 NDC:0173-0810-63 105 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022345 04/19/2012
POTIGA
ezogabine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0812
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZOGABINE (EZOGABINE) EZOGABINE 200 mg
Inactive Ingredi |
