Topiramate
Product Images NDC 10544-489

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 10544-489). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Blenheim Pharmacal, 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.

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Table 2 (Part 1)

A data table showing adverse reactions by body system for Topiramate at dosages of 50 mg/day and 400 mg/day. It lists the number of subjects experiencing various side effects such as asthenia, leg pain, paresthesia, dizziness, diarrhea, and weight decrease among others, categorized by system disorders.*

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Table 2 (Part 2)

A data table listing various adverse reactions grouped by disorder categories such as Psychiatric Disorders, Reproductive Disorders (female), Red Blood Cell Disorders, Resistance Mechanism Disorders, Respiratory System Disorders, Skin and Appendages Disorders, Special Senses Other Disorders, and Urinary System Disorders. The table provides numeric values representing the percentage of patients reporting each adverse reaction, including symptoms like somnolence, anorexia, depression, bronchitis, rash, and cystitis among others.*

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Table 3 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 03)

A data table presenting the percentage of patients reporting various adverse reactions to Topiramate at dosages of 50 mg/day and 400 mg/day. The table categorizes adverse events by body system, including general disorders, nervous system, gastrointestinal, metabolic, psychiatric, resistance mechanism, respiratory, and skin disorders. Specific events and their reported percentages for both dosages are listed, with a footnote clarifying that patients may report multiple adverse events.*

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Table 4 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 04)

A data table presenting the percentage of patients experiencing various adverse reactions by body system at different Topiramate dosages (placebo, 200-400 mg/day, 600-1000 mg/day). Adverse reactions cover disorders such as nervous system, gastrointestinal, psychiatric, reproductive, respiratory, skin, urinary, and hematologic systems, with detailed incidence percentages across dosage groups.*

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Table 5 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 05)

A data table comparing adverse reactions by body system for Topiramate dosage of 200 mg/day versus placebo. It lists reaction counts including fatigue, chest pain, hypertension, paresthesia, dizziness, tremor, abdominal pain, somnolence, anorexia, nervousness, and others, with annotations explaining patient trial conditions and data representation.*

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Table 6 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 06)

Data table showing adverse reaction rates for Topiramate by dosage group (200 mg/day, 400 mg/day, 600-1000 mg/day) compared with placebo. Adverse reactions include fatigue, nervousness, difficulty with concentration, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease, with numerical values representing incidence counts in each group.*

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Table 7 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 07)

A table presenting adverse reactions categorized by body system comparing the incidence rates in patients receiving placebo versus Topiramate (N=98). The table includes general disorders, nervous system, gastrointestinal, cardiac, metabolic, psychiatric, reproductive, respiratory, skin, urinary, vision, and white cell disorders, with numerical values indicating the number of patients affected in each group.*

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Structure Of Topiramate (D3343e6b 6ff3 4ba4 A138 4636dd463fec 08)

Chemical structure of Topiramate showing the molecular arrangement with oxygen, sulfur, nitrogen, and carbon atoms depicted in a ring and side chains.*

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Figure 1 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 09)

A cumulative incidence curve chart displaying Topiramate treatment groups at 50 mg/day and 400 mg/day doses. The y-axis shows cumulative rates for time to first seizure, and the x-axis represents time in days up to 500 days. The chart includes a p-value of 0.0002 comparing groups.*

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Table 12 (D3343e6b 6ff3 4ba4 A138 4636dd463fec 10)

A data table showing protocol efficacy results of Topiramate dosage ranging from placebo to 1000 mg/day and approximately 6 mg/kg/day. It includes median percentage reduction and responder percentages across various studies in adults and pediatric patients for seizure types including partial onset seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome. Comparisons with placebo and statistical significance annotations are included.*

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Glenmark Logo (D3343e6b 6ff3 4ba4 A138 4636dd463fec 11)

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Label Graphic-50mg 60s (D3343e6b 6ff3 4ba4 A138 4636dd463fec 12)

Topiramate Tablets USP 50mg packaging label for 60 tablets, labeled by Blenheim Pharmacal, Inc. Includes dosage form, strength, quantity, storage instructions, NDC 10544-847-60, and manufacturer details. Barcode and lot/expiration placeholders are also shown.*

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Label Graphic-100mg 60s (D3343e6b 6ff3 4ba4 A138 4636dd463fec 13)

Topiramate Tablets USP 100mg bottle label showing 60 tablets. The label includes dosage form, strength, NDC number 10544-489-60, manufacturer Blenheim Pharmacal, Inc., lot number and expiration date placeholders, storage instructions, and barcode.*

* 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.