Topiramate

TOPIRAMATE — topiramate capsule, extended release
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1656-3

Topiramate extended-release Capsules 25 mg

Rx only

30 Capsules

25 mg label
(click image for full-size original)

NDC 70771-1657-3

Topiramate extended-release Capsules 50 mg

Rx only

30 Capsules

50 mg label
(click image for full-size original)

NDC 70771-1658-3

Topiramate extended-release Capsules 100 mg

Rx only

30 Capsules

100 mg label
(click image for full-size original)

NDC 70771-1659-3

Topiramate extended-release Capsules 150 mg

Rx only

30 Capsules

150 mg label
(click image for full-size original)

NDC 70771-1660-3

Topiramate extended-release Capsules 200 mg

Rx only

30 Capsules

200 mg label
(click image for full-size original)
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1656
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
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color PINK (FLESH OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 1039
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1656-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1656-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208949 01/17/2023
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1657
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 50 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color WHITE (IVORY OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code 1040
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1657-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1657-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208949 01/17/2023
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 100 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color ORANGE (MEDIUM ORANGE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 1041
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1658-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1658-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208949 01/17/2023
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1659
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 150 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color WHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code 1042
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1659-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1659-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208949 01/17/2023
TOPIRAMATE
topiramate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1660
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 200 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (10 MPA.S)
ETHYLCELLULOSE (45 MPA.S)
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color GREEN (LIGHT GREEN OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code 1043
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1660-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1660-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208949 01/17/2023
Labeler — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1656), ANALYSIS (70771-1657), ANALYSIS (70771-1658), ANALYSIS (70771-1659), ANALYSIS (70771-1660), MANUFACTURE (70771-1656), MANUFACTURE (70771-1657), MANUFACTURE (70771-1658), MANUFACTURE (70771-1659), MANUFACTURE (70771-1660)

Revised: 12/2022 Zydus Lifesciences Limited

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