TOPIRAMATE- topiramate tablet, film coated 
Cadila Healthcare Limited

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TOPIRAMATE TABLETS and TOPIRAMATE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-647-14 in bottle of 60 tablets

Topiramate Tablets USP, 25 mg

60 tablets

Rx only

Topiramate Tablets

NDC 65841-648-14 in bottle of 60 tablets

Topiramate Tablets USP, 50 mg

60 tablets

Rx only

Topiramate Tablets

NDC 65841-649-14 in bottle of 60 tablets

Topiramate Tablets USP, 100 mg

60 tablets

Rx only

Topiramate Tablets

NDC 65841-650-14 in bottle of 60 tablets

Topiramate Tablets USP, 200 mg

60 tablets

Rx only

Topiramate Tablets
TOPIRAMATE 
topiramate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-647
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZD;16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-647-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
2NDC:65841-647-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
3NDC:65841-647-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
4NDC:65841-647-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07823503/27/2009
TOPIRAMATE 
topiramate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-648
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE50 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZD;15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-648-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
2NDC:65841-648-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
3NDC:65841-648-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
4NDC:65841-648-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07823503/27/2009
TOPIRAMATE 
topiramate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-649
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE100 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZD;14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-649-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
2NDC:65841-649-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
3NDC:65841-649-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
4NDC:65841-649-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07823503/27/2009
TOPIRAMATE 
topiramate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-650
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code ZD;13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-650-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
2NDC:65841-650-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
3NDC:65841-650-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
4NDC:65841-650-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07823503/27/2009
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-647, 65841-648, 65841-649, 65841-650) , MANUFACTURE(65841-647, 65841-648, 65841-649, 65841-650)

Revised: 9/2020
Document Id: ecd79705-832b-42c4-be26-82d93432cf7c
Set id: 57016639-89fe-43ad-89c4-5e7a756dddec
Version: 6
Effective Time: 20200914
 
Cadila Healthcare Limited