NDC Code(s) : 43602-457-30, 43602-457-10, 43602-458-30, 43602-458-10, 43602-459-30, 43602-459-10, 43602-460-30, 43602-460-10
Packager : Ascent Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TOPIRAMATETopiramate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-457
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391) 		TOPIRAMATE25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color yellow (Cream colored) Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code T;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-457-3030 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
2NDC:43602-457-101000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215414 08/26/2021
TOPIRAMATETopiramate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-458
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391) 		TOPIRAMATE50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow (Light yellow) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code T;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-458-3030 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
2NDC:43602-458-101000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215414 08/26/2021
TOPIRAMATETopiramate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-459
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391) 		TOPIRAMATE100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code T;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-459-3030 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
2NDC:43602-459-101000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215414 08/26/2021
TOPIRAMATETopiramate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-460
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391) 		TOPIRAMATE200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color orange Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code T;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-460-3030 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
2NDC:43602-460-101000 in 1 BOTTLE Type 0: Not a Combination Product26/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215414 08/26/2021

LABELER - Ascent Pharmaceuticals, Inc.(080938961)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals, Inc. 080938961 manufacture(43602-457, 43602-458, 43602-459, 43602-460), analysis(43602-457, 43602-458, 43602-459, 43602-460), pack(43602-457, 43602-458, 43602-459, 43602-460)

PRINCIPAL DISPLAY PANEL

25mg

25mg

25mg

25mg