Zonisamide
Product Images NDC 61919-591

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Zonisamide (NDC 61919-591). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, 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 Description (Chart)

A line graph comparing the percentage reduction in all partial seizures rate between Zonisamide and placebo treatment arms. The x-axis represents the percentage of patients, and the y-axis shows the percentage reduction in seizures, with improvement at the top and worsening at the bottom. Two lines indicate seizure rate changes for patients taking Zonisamide versus placebo.*

FDA Label Image

Image Description (Label)

Zonisamide 50 mg capsule bottle label by Direct Rx, containing 60 capsules. The label indicates the product is generic for Zonegran and includes the active ingredient Zonisamide USP 50 mg. The label also lists lot number, expiration date (05/18), warnings about drowsiness and dizziness, and storage instructions. The NDC is 61919-591-60.*

FDA Label Image

Image Description (Molecule)

Chemical structure of Zonisamide showing a benzisoxazole ring attached to a methanesulfonamide group.*

FDA Label Image

Image Description (Picture)

FDA Label Image

Image Description (Picture2)

This image shows the manufacturer information for Zonisamide by Direct Rx. It states that the product is manufactured for Glenmark Pharmaceuticals Inc., located in Mahwah, NJ, USA. Contact information includes a phone number and a website. The date July 2015 is also shown.*

FDA Label Image

Image Description (Table1)

A data table titled 'Median % Reduction in All Partial Seizures and % Responders in Primary Efficacy Analyses: Intent-To-Treat Analysis'. The table compares median percentage reductions in partial seizures and percentage of responders for Zonisamide versus placebo across three studies over various weeks. It includes sample sizes (n) and percentage values for each study period and treatment group.*

FDA Label Image

Image Description (Table2)

Data table presenting the median percentage reduction in partial seizures and percentage of responders comparing Zonisamide versus placebo across different dose groups and time periods in a clinical study. The table details results for doses 100-400 mg/day, 100 mg/day, and 200 mg/day with corresponding sample sizes and data for weeks 1-12, 1-5, and 2-6 respectively.*

FDA Label Image

Image Description (Table3)

A data table titled 'Risk by indication for antiepileptic drugs in the pooled analysis' showing incidence rates and risk differences of events per 1000 patients across indications: Epilepsy, Psychiatric, Other, and Total. Columns compare placebo and drug patient event rates, relative risk, and additional risk differences.*

FDA Label Image

Image Description (Table4 1)

Data table showing the incidence percentages of various adverse events by body system/preferred term for Zonisamide and placebo groups. Events include headache, abdominal pain, flu syndrome, anorexia, nausea, diarrhea, dyspepsia, constipation, and dry mouth, with corresponding percentages for Zonisamide (n=269) and placebo (n=230) groups.*

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Image Description (Table4 2)

A data table listing metabolic, nutritional, nervous system, and neuropsychiatric adverse events with associated frequency counts. Categories include weight loss, dizziness, ataxia, nystagmus, paresthesia, confusion, difficulty concentrating, difficulty with memory, and mental slowing.*

FDA Label Image

Image Description (Table4 3)

A data table presenting adverse neuropsychiatric and cognitive dysfunction symptoms associated with Zonisamide. It categorizes symptoms into non-psychosis-related, psychosis-related, and CNS depression groups, listing associated conditions such as agitation, depression, insomnia, anxiety, schizophrenia-related behavior, somnolence, fatigue, and tiredness, with corresponding numeric values presumably indicating incidence or severity.*

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Image Description (Table4 4)

A data table listing adverse events categorized under neuropsychiatric and cognitive dysfunction, respiratory, skin and appendages, and special senses. It includes specific events such as speech abnormalities, difficulties in verbal expression, rhinitis, rash, diplopia, and taste perversion, with associated numerical values in adjacent columns.*

FDA Label Image

Image Description (Table5)

A data table presenting the dosage strengths, capsule descriptions, packaging counts, and corresponding NDC numbers for Zonisamide capsules. It lists 25 mg, 50 mg, and 100 mg strengths, with specific capsule color descriptions and printing details, alongside package sizes of 100 and 500 counts and their respective NDC codes.*

* 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.