TOPIRAMATE- topiramate capsule, extended release 
Zydus Lifesciences Limited

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TOPIRAMATE EXTENDED-RELEASE CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1315-3

Topiramate extended-release capsules, 25 mg

30 capsules

Rx only

25 mg

NDC 70771-1316-3

Topiramate extended-release capsules, 50 mg

30 capsules

Rx only

50 mg

NDC 70771-1317-3

Topiramate extended-release capsules, 100 mg

30 capsules

Rx only

100 mg

NDC 70771-1858-3

Topiramate extended-release capsules, 200 mg

30 capsules

Rx only

200 mg
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1315
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 863
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1315-330 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
2NDC:70771-1315-990 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
3NDC:70771-1315-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
4NDC:70771-1315-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
5NDC:70771-1315-410 in 1 CARTON04/05/2018
5NDC:70771-1315-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20738204/05/2018
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1316
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE50 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code 864
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1316-330 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
2NDC:70771-1316-990 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
3NDC:70771-1316-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
4NDC:70771-1316-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
5NDC:70771-1316-410 in 1 CARTON04/05/2018
5NDC:70771-1316-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20738204/05/2018
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1317
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE100 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
ShapeCAPSULESize23mm
FlavorImprint Code 769
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1317-330 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
2NDC:70771-1317-990 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
3NDC:70771-1317-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
4NDC:70771-1317-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
5NDC:70771-1317-410 in 1 CARTON04/05/2018
5NDC:70771-1317-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20738204/05/2018
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1858
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code 358
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1858-330 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2023
2NDC:70771-1858-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2023
3NDC:70771-1858-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2023
4NDC:70771-1858-83 in 1 CARTON11/13/2023
4NDC:70771-1858-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20738211/13/2023
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1315, 70771-1316, 70771-1317, 70771-1858) , MANUFACTURE(70771-1315, 70771-1316, 70771-1317, 70771-1858)

Revised: 11/2023
Document Id: 709dd70b-24e1-435f-8373-02e6dd538b2c
Set id: 9a943af0-1c6d-43c2-830a-f303baa16124
Version: 6
Effective Time: 20231108
 
Zydus Lifesciences Limited