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Topiramate ER Capsules

Dosage form: capsule, extended release

Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1315-3

Topiramate extended-release capsules, 25 mg

30 capsules

Rx only

NDC 70771-1316-3

Topiramate extended-release capsules, 50 mg

30 capsules

Rx only

NDC 70771-1317-3

Topiramate extended-release capsules, 100 mg

30 capsules

Rx only

TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1315
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CELLULOSE, MICROCRYSTALLINE
ETHYLCELLULOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
GELATIN
HYDROGENATED CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color WHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 863
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1315-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:70771-1315-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:70771-1315-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:70771-1315-5 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
5 NDC:70771-1315-4 10 BLISTER PACK in 1 CARTON
5 NDC:70771-1315-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207382 04/05/2018
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1316
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
ETHYLCELLULOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
HYPROMELLOSE, UNSPECIFIED
HYDROGENATED CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
POVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TRIETHYL CITRATE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
BUTYL ALCOHOL
ALCOHOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
WATER
Product Characteristics
Color WHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 864
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1316-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:70771-1316-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:70771-1316-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:70771-1316-5 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
5 NDC:70771-1316-4 10 BLISTER PACK in 1 CARTON
5 NDC:70771-1316-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207382 04/05/2018
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70771-1317
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CELLULOSE, MICROCRYSTALLINE
ETHYLCELLULOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
GELATIN
HYDROGENATED CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color WHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code 769
Contains
Packaging
# Item Code Package Description
1 NDC:70771-1317-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
2 NDC:70771-1317-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 NDC:70771-1317-1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 NDC:70771-1317-5 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
5 NDC:70771-1317-4 10 BLISTER PACK in 1 CARTON
5 NDC:70771-1317-2 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207382 04/05/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS(70771-1315, 70771-1316, 70771-1317), MANUFACTURE(70771-1315, 70771-1316, 70771-1317)
Cadila Healthcare Limited

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