TOPIRAMATE - topiramate capsule, coated pellets 
Zydus Lifesciences Limited

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TOPIRAMATE TABLETS and TOPIRAMATE CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-651-14 in bottle of 60 capsules

Topiramate Capsules USP, 15 mg

60 capsules

Rx only

Topiramate Capsules (Sprinkle), 15 mg

NDC 65841-652-14 in bottle of 60 capsules

Topiramate Capsules USP, 25 mg

60 capsules

Rx only

Topiramate Capsules (Sprinkle), 25 mg
TOPIRAMATE 
topiramate capsule, coated pellets
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-651
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE15 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA63;15mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-651-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
2NDC:65841-651-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
3NDC:65841-651-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
4NDC:65841-651-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
5NDC:65841-651-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887710/14/2009
TOPIRAMATE 
topiramate capsule, coated pellets
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-652
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE25 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA64;25mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-652-1728 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
2NDC:65841-652-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
3NDC:65841-652-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
4NDC:65841-652-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
5NDC:65841-652-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
6NDC:65841-652-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887710/14/2009
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-651, 65841-652) , MANUFACTURE(65841-651, 65841-652)

Revised: 10/2022
Document Id: 8e90e7b9-efed-46d5-925b-4123ac9d6b37
Set id: 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b
Version: 9
Effective Time: 20221031
 
Zydus Lifesciences Limited