Topiramate Tablet, Film Coated
Product Images NDC 68382-141

7 FDA label images from Zydus Pharmaceuticals Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 68382-141). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

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39703b05 F774 4aed 9792 000a61531553 01
Chemical structure of topiramate, depicting its molecular arrangement with rings, oxygen atoms, methyl groups, and a sulfonamide group, consistent with the active ingredient topiramate in the product label.*
FDA Label Image

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A line graph showing the cumulative rates for time to first seizure over days (0 to 500) comparing topiramate 50 mg/day (solid line) and 400 mg/day (dashed line) groups. The 50 mg/day group shows higher cumulative seizure rates over time compared to the 400 mg/day group, with a noted p-value of 0.0002 indicating statistical significance.*
FDA Label Image

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39703b05 F774 4aed 9792 000a61531553 03
A bar chart depicting the change from baseline to double-blind phase in average monthly migraine period rate for placebo and topiramate doses 50 mg/day, 100 mg/day, and 200 mg/day, from two studies (Study 11 and Study 12). The chart shows decreasing migraine rates with increasing topiramate dose, with statistical significance indicated (* p <0.010, ** p <0.001). Sample sizes for each group are noted above the bars.*
FDA Label Image

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39703b05 F774 4aed 9792 000a61531553 04
Topiramate Tablets, USP 25 mg film-coated tablets label featuring Zydus Pharmaceuticals as labeler. The label indicates a package size of 60 tablets for oral use. The label includes dosage strength in a highlighted yellow box and contains additional storage and dispensing instructions, along with a barcode and manufacturer information.*
FDA Label Image

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Label for Topiramate Tablets, USP 50 mg film-coated tablets, containing 60 tablets per bottle. The product is labeled for oral use and distributed by Zydus Pharmaceuticals USA Inc. The label includes drug information, storage instructions to keep at 20°C to 25°C, and a warning to keep out of reach of children.*
FDA Label Image

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39703b05 F774 4aed 9792 000a61531553 06
Topiramate Tablets USP 100 mg film-coated tablets label from Zydus Pharmaceuticals USA Inc. The label indicates a package containing 60 tablets, for prescription use only. It provides storage instructions, dosage direction note, and a warning to keep the medication out of children's reach. The label includes manufacturer and distributor information with a barcode and a reminder for pharmacists to dispense the Medication Guide separately.*
FDA Label Image

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Label for Topiramate Tablets, USP 200 mg oral film-coated tablets by Zydus Pharmaceuticals USA Inc. The label indicates a package of 60 tablets, Rx only, with storage instructions between 20°C to 25°C. Manufacturer is Cadila Healthcare Ltd., India, distributed by Zydus Pharmaceuticals (USA) Inc.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.