NDC Code 43602-458-30 - Topiramate

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

TOPIRAMATETopiramate TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE(UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-457-30	30 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021
2	NDC:43602-457-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215414	08/26/2021

TOPIRAMATETopiramate TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE(UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-458-30	30 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021
2	NDC:43602-458-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215414	08/26/2021

TOPIRAMATETopiramate TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE(UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	100 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-459-30	30 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021
2	NDC:43602-459-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215414	08/26/2021

TOPIRAMATETopiramate TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE(UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	200 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-460-30	30 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021
2	NDC:43602-460-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215414	08/26/2021

LABELER - Ascent Pharmaceuticals, Inc.(080938961)

NDC 43602-458-30
API & Excipient Details