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

NDC 70771-1657-3

Topiramate extended-release Capsules 50 mg

Rx only

30 Capsules

NDC 70771-1658-3

Topiramate extended-release Capsules 100 mg

Rx only

30 Capsules

NDC 70771-1659-3

Topiramate extended-release Capsules 150 mg

Rx only

30 Capsules

NDC 70771-1660-3

Topiramate extended-release Capsules 200 mg

Rx only

30 Capsules

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