Zonisamide
Product Images NDC 53217-301

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Zonisamide (NDC 53217-301). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals Llc, 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

Image (Zonisamide Usp 1)

A table titled 'Median % Reduction in All Partial Seizures and % Responders in Primary Efficacy Analyses: Intent-To-Treat Analysis' displaying data for ZONEGRAN compared to placebo across three studies. It includes median percentage reductions in partial seizures and percentage of responders for different weeks and sample sizes, with statistically significant values marked.*

FDA Label Image

Image (Zonisamide Usp 2)

A data table titled 'Median % Reduction in All Partial Seizures and % Responders for Dose Analyses in Study 1: Intent-To-Treat Analysis' comparing median percentage reduction in partial seizures and percentage of responders between zonisamide and placebo across various dose groups and time periods. The table includes dose groups of 100 to 400 mg/day, 100 mg/day, and 200 mg/day with results for zonisamide and placebo over weeks 1 to 12 or weeks 1 to 6, showing statistically significant differences marked by an asterisk for zonisamide compared to placebo.*

FDA Label Image

Image (Zonisamide Usp 3)

A line graph depicting the proportion of patients achieving different levels of seizure reduction in ZONEGRAN (zonisamide) and placebo groups from Studies 2 and 3. The x-axis shows the percentage of patients, and the y-axis shows percent reduction in all partial seizure rate, with two lines representing ZONEGRAN and placebo treatment arms.*

FDA Label Image

Image (Zonisamide Usp 4)

A data table titled 'Table 4. Adverse Reactions in Placebo-Controlled, Add-On Trials' comparing the incidence of various adverse reactions between patients treated with zonisamide (n=269) and placebo (n=230). It categorizes reactions by body systems such as body as a whole, digestive, hematologic and lymphatic, metabolic and nutritional, nervous system, neuropsychiatric and cognitive dysfunction subtypes, respiratory, skin and appendages, and special senses, showing the frequency percentages for both treatment groups.*

FDA Label Image

Image Description (Zonisamide Usp 5)

This is a prescription drug label for Zonisamide USP 100 mg capsules, packaged in a bottle containing 60 capsules. The label identifies the product as generic for Zonegran and shows Aidarex Pharmaceuticals LLC as the labeler. The capsules are described as brown and white oblong with imprints MG 228 on one side. The label includes dosing instructions and manufacturer details for Invagen Pharmaceuticals, 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.