Topiramate Extended-release Capsules

SPL v6

SPL

SPL Set ID 9a943af0-1c6d-43c2-830a-f303baa16124

Route

ORAL

Published

Effective Date 2023-11-08

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Topiramate (25 mg)

Inactive Ingredients

Cellulose, Microcrystalline Ethylcellulose, Unspecified Ferrosoferric Oxide Gelatin Hydrogenated Castor Oil Hypromellose, Unspecified Polyethylene Glycol, Unspecified Potassium Hydroxide Povidone Propylene Glycol Shellac Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate Water Alcohol Ammonia Butyl Alcohol Isopropyl Alcohol Hydroxypropyl Cellulose (90000 Wamw)

Identifiers & Packaging

Pill Appearance

Imprint: 358 Shape: capsule Color: white Size: 18 mm Size: 21 mm Size: 23 mm Size: 24 mm Score: 1

Marketing Status

ANDA Active Since 2023-11-13

Description

NDC 70771-1315-3 Topiramate extended-release capsules, 25 mg 30 capsules Rx only NDC 70771-1316-3 Topiramate extended-release capsules, 50 mg 30 capsules Rx only NDC 70771-1317-3 Topiramate extended-release capsules, 100 mg 30 capsules Rx only NDC 70771-1858-3 Topiramate extended-release capsules, 200 mg 30 capsules Rx only

Medication Information

Description

Package Label.principal Display Panel

NDC 70771-1315-3

Topiramate extended-release capsules, 25 mg

30 capsules

Rx only

NDC 70771-1316-3

Topiramate extended-release capsules, 50 mg

30 capsules

Rx only

NDC 70771-1317-3

Topiramate extended-release capsules, 100 mg

30 capsules

Rx only

NDC 70771-1858-3

Topiramate extended-release capsules, 200 mg

30 capsules

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1315-3

Topiramate extended-release capsules, 25 mg

30 capsules

Rx only

NDC 70771-1316-3

Topiramate extended-release capsules, 50 mg

30 capsules

Rx only

NDC 70771-1317-3

Topiramate extended-release capsules, 100 mg

30 capsules

Rx only

NDC 70771-1858-3

Topiramate extended-release capsules, 200 mg

30 capsules

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1315-3 Topiramate extended-release capsules, 25 mg 30 capsules Rx only NDC 70771-1316-3 Topiramate extended-release capsules, 50 mg 30 capsules Rx only NDC 70771-1317-3 Topiramate extended-release capsules, 100 mg 30 capsules Rx only NDC 70771-1858-3 Topiramate extended-release capsules, 200 mg 30 capsules Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:39:18.146404 · Updated: 2026-03-14T21:57:18.432733