Topiramate Extended-release Capsules, For Oral Use

SPL v3

SPL

SPL Set ID 57b5d67b-b29b-4c18-a53d-51d5374f3be3

Route

ORAL

Published

Effective Date 2023-09-28

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Topiramate (25 mg)

Inactive Ingredients

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 Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: 1043 Shape: capsule Color: pink Color: white Color: orange Color: green Size: 14 mm Size: 18 mm Size: 19 mm Size: 22 mm Size: 23 mm Score: 1

Marketing Status

ANDA Active Since 2023-01-17

Description

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

Medication Information

Description

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

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"7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYL CITRATE", "unii": "8Z96QXD6UM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOPIRAMATE", "unii": "0H73WJJ391", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ETHYLCELLULOSE (10 MPA.S)", "unii": "3DYK7UYZ62", "classCode": "IACT", "strengthNumerator": "", 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"", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM HYDROXIDE", "unii": "WZH3C48M4T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYL CITRATE", "unii": "8Z96QXD6UM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", 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Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:39:00.023918 · Updated: 2026-03-14T21:56:18.712126