TOPIRAMATE- topiramate capsule, extended release 
Zydus Lifesciences Limited

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TOPIRAMATE extended-release capsules, for oral use

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1656-3

Topiramate extended-release Capsules 25 mg

Rx only

30 Capsules

25 mg label

NDC 70771-1657-3

Topiramate extended-release Capsules 50 mg

Rx only

30 Capsules

50 mg label

NDC 70771-1658-3

Topiramate extended-release Capsules 100 mg

Rx only

30 Capsules

100 mg label

NDC 70771-1659-3

Topiramate extended-release Capsules 150 mg

Rx only

30 Capsules

150 mg label

NDC 70771-1660-3

Topiramate extended-release Capsules 200 mg

Rx only

30 Capsules

200 mg label
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1656
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE25 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINK (FLESH OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code 1039
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1656-990 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
2NDC:70771-1656-330 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20894901/17/2023
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1657
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE50 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (IVORY OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 1040
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1657-330 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
2NDC:70771-1657-990 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20894901/17/2023
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1658
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE100 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGE (MEDIUM ORANGE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 1041
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1658-330 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
2NDC:70771-1658-990 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20894901/17/2023
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1659
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE150 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size22mm
FlavorImprint Code 1042
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1659-330 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
2NDC:70771-1659-990 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20894901/17/2023
TOPIRAMATE 
topiramate capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1660
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE200 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
ETHYLCELLULOSE (45 MPA.S) (UNII: V7AD894FAZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (LIGHT GREEN OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size23mm
FlavorImprint Code 1043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1660-330 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
2NDC:70771-1660-990 in 1 BOTTLE; Type 0: Not a Combination Product01/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20894901/17/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1656, 70771-1657, 70771-1658, 70771-1659, 70771-1660) , MANUFACTURE(70771-1656, 70771-1657, 70771-1658, 70771-1659, 70771-1660)

Revised: 9/2023
Document Id: 432dc54b-f28b-48c9-b417-2fbae070f41b
Set id: 57b5d67b-b29b-4c18-a53d-51d5374f3be3
Version: 3
Effective Time: 20230928
 
Zydus Lifesciences Limited