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Topiramate Capsules

Dosage form: sprinkle capsules

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

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-651-14 in bottle of 60 capsules

Topiramate Capsules USP, 15 mg

60 capsules

Rx only

NDC 65841-652-14 in bottle of 60 capsules

Topiramate Capsules USP, 25 mg

60 capsules

Rx only

TOPIRAMATE
topiramate capsule, coated pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-651
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 15 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
CELLULOSE ACETATE
GELATIN
POVIDONE
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ZA63;15mg
Contains
Packaging
# Item Code Package Description
1 NDC:65841-651-14 60 CAPSULE, COATED PELLETS in 1 BOTTLE
2 NDC:65841-651-16 90 CAPSULE, COATED PELLETS in 1 BOTTLE
3 NDC:65841-651-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE
4 NDC:65841-651-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE
5 NDC:65841-651-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078877 10/14/2009
TOPIRAMATE
topiramate capsule, coated pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-652
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
HYPROMELLOSES
CELLULOSE ACETATE
GELATIN
POVIDONE
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code ZA64;25mg
Contains
Packaging
# Item Code Package Description
1 NDC:65841-652-17 28 CAPSULE, COATED PELLETS in 1 BOTTLE
2 NDC:65841-652-14 60 CAPSULE, COATED PELLETS in 1 BOTTLE
3 NDC:65841-652-16 90 CAPSULE, COATED PELLETS in 1 BOTTLE
4 NDC:65841-652-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE
5 NDC:65841-652-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE
6 NDC:65841-652-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078877 10/14/2009
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS(65841-651, 65841-652), MANUFACTURE(65841-651, 65841-652)
Cadila Healthcare Limited

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