Home SPL Set DailyMed Topiramate Tablets And Topiramate Capsules Topiramate Tablets And Topiramate Capsules SPL v11 SPL SPL Set ID 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b Route ORAL Published Effective Date 2024-10-25 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Topiramate (15 mg) Inactive Ingredients Hypromelloses Cellulose Acetate Gelatin Povidone Sodium Lauryl Sulfate Sucrose Talc Titanium Dioxide Water Ferrosoferric Oxide Potassium Hydroxide Propylene Glycol Shellac Identifiers & Packaging Pill Appearance Imprint: 50mg Shape: capsule Color: white Size: 18 mm Size: 19 mm Size: 22 mm Score: 1 Marketing Status ANDA Active Since 2024-10-24 Description NDC 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only NDC 65841-100-14 in bottle of 60 capsules Topiramate Capsules USP, 50 mg 60 capsules Rx only Medication Information Description NDC 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only NDC 65841-100-14 in bottle of 60 capsules Topiramate Capsules USP, 50 mg 60 capsules Rx only Package Label.principal Display Panel NDC 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only NDC 65841-100-14 in bottle of 60 capsules Topiramate Capsules USP, 50 mg 60 capsules Rx only Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only NDC 65841-100-14 in bottle of 60 capsules Topiramate Capsules USP, 50 mg 60 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capsules Topiramate Capsules USP, 50 mg 60 capsules Rx only"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:30.011734 · Updated: 2026-03-14T22:15:52.273968