Topiramate Tablet
Product Images NDC 72865-316

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Topiramate (NDC 72865-316). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, 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

100 mg-1000 (100 mg 1000s)

Topiramate Tablets, USP 100 mg oral tablets packaging label from XLCare Pharmaceuticals, Inc. The label includes the NDC 72865-315-10, directions to verify prescription before dispensing, and a package size of 1000 tablets. Storage instructions and manufacturer details for Ascent Pharmaceuticals, Inc. and XLcare Pharmaceuticals, Inc. are provided.*

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100 mg-60 (100 mg 60s)

Topiramate Tablets USP 100 mg bottle label from XLCare Pharmaceuticals Inc. It contains 60 oral tablets with a caution to verify prescription before dispensing. The label includes storage instructions, manufacturer details (Ascent Pharmaceuticals, Inc.), and advises dispensing with medication guide. NDC 72865-315-60 is shown with barcode and no varnish on the label.*

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200 mg-1000 (200 mg 1000s)

Topiramate Tablets USP 200 mg oral tablets by XLCare Pharmaceuticals Inc. The label shows the NDC 72865-316-10 and indicates a bottle containing 1000 tablets. It includes a caution to verify prescriptions before dispensing and instructs pharmacists to provide a Medication Guide. Storage instructions, manufacturer details (Ascent Pharmaceuticals, Inc.), and dispensing warnings are also present.*

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200 mg-60 (200 mg 60s)

Topiramate Tablets USP 200 mg oral tablets label by XLCare Pharmaceuticals, Inc. The label indicates a package of 60 tablets with a note to verify prescription before dispensing and to dispense medication guide to patients. Storage instructions and manufacturer information for Ascent Pharmaceuticals, Inc. and XLCare Pharmaceuticals, Inc. are also shown on the label.*

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25 mg-1000 (25 mg 1000s)

Label for Topiramate Tablets, USP 25 mg, an oral tablet manufactured by Ascent Pharmaceuticals, Inc. and labeled for XLCare Pharmaceuticals, Inc. The label includes dosage strength, NDC 72865-313-10, 1000 tablets count, storage instructions, cautionary notes, and manufacturer addresses. The label is primarily white with blue and gold accents.*

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25 mg-60 (25 mg 60s)

Topiramate Tablets USP 25 mg oral tablets label by XL Care Pharmaceuticals, Inc. The label states the product contains 60 tablets, includes a caution to verify prescription before dispensing, and provides storage instructions. Manufactured by Ascent Pharmaceuticals, Inc. and distributed by XL Care Pharmaceuticals, Inc.*

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50 mg-1000 (50 mg 1000s)

Topiramate Tablets USP 50 mg oral tablets label by XLCare Pharmaceuticals, Inc. The label indicates 1000 tablets in the container. It includes storage instructions, a caution to verify prescription before dispensing, and manufacturing details for Ascent Pharmaceuticals, Inc. and XLCare Pharmaceuticals, Inc.*

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50 mg-60 (50 mg 60s)

TOPIRAMATE 50 mg tablets label from XLCare Pharmaceuticals, Inc. The label shows the NDC number 72865-314-60 and indicates 60 tablets per container. Instructions and storage information are printed, including a caution to verify prescription before dispensing and a note that the medication guide should be provided separately to patients.*

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Figure1 (Figure 1)

A Kaplan-Meier curve chart showing cumulative rates for time to first seizure over 500 days comparing two groups: Topiramate 50 mg/day (N=234) and Topiramate 400 mg/day (N=236). The horizontal axis represents time in days, and the vertical axis shows cumulative rates for time to first seizure. The chart includes a p-value of 0.0002 indicating statistical comparison between groups.*

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Figure2 (Figure 2)

A bar graph comparing change from baseline to double-blind phase in average monthly migraine period rate (LSB) for placebo and Topiramate doses of 50 mg/day, 100 mg/day, and 200 mg/day. The graph includes data from two studies, Study 11 and Study 12, represented with different bar patterns. Statistical significance is indicated for several Topiramate groups, with p-values less than 0.01 and 0.001.*

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Mg1 (Mg1)

A text panel listing side effects of topiramate tablets, including feeling tired, loss of appetite, changes in heartbeat, and trouble thinking clearly. The text is presented as bullet points describing patient experiences related to the medication.*

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Mg2 (Mg2)

This image shows a text panel listing potential side effects or symptoms, including suicidal thoughts, depression, anxiety, restlessness, panic attacks, insomnia, irritability, aggressive behavior, dangerous impulses, mania, and other behavioral or mood changes. The information appears to be part of a drug safety or warning section related to TOPIRAMATE tablets.*

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Mg3 (Mg3)

This image shows a medication information panel listing potential side effects of a drug, including symptoms such as tingling of the arms and legs, nervousness, nausea, diarrhea, weight loss, speech problems, dizziness, sleepiness, difficulty with memory, pain in the abdomen, fever, abnormal vision, and decreased feeling or sensitivity in the skin.*

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Tab1 (Tab1)

A table titled 'Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older' showing a weekly dosing schedule for morning and evening doses of Topiramate tablets, starting at 25 mg twice daily in Week 1 and increasing incrementally to 200 mg twice daily by Week 6.*

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Tab2 (Tab2)

A table titled 'Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age' displaying Topiramate dosing by weight categories in kilograms. It lists minimum and maximum maintenance doses in mg/day, noting doses are given in two equally divided doses.*

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Tab3 (Tab3)

Table titled 'Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older' showing a four-week dosing schedule with morning and evening doses of topiramate starting from no morning dose and 25 mg evening dose in Week 1, increasing to 50 mg for both morning and evening doses by Week 4.*

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Tab4 (Tab4)

A data table titled 'Risk by Indication for Antiepileptic Drugs in the Pooled Analysis' presenting incidence of events per 1000 patients across different indications: Epilepsy, Psychiatric, and Other. It compares placebo patients with drug patients, showing relative risk and risk difference for the drug patients versus placebo patients.*

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Structural (Structural Formula)

Chemical structure of Topiramate, showing its molecular framework including multiple oxygen, sulfur, and methyl functional groups characteristic of the compound.*

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Tab12 (Table 12)

A data table titled 'Topiramate Dose Summary During the Stabilization Periods of Each of Six Double-Blind, Placebo-Controlled, Adjunctive Trials in Adults with Partial-Onset Seizures.' It summarizes stabilization doses, placebo tablet counts, and target topiramate dosages (mg/day) across six studies, showing participant numbers, mean doses, and median doses for placebo and various topiramate dose levels.*

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Tab13 (Table 13)

A data table titled 'Efficacy Results in Double-Blind, Placebo-Controlled, Adjunctive Epilepsy Trials' presenting study numbers, sample sizes, median percentage reduction in seizures, and percentage of responders for various target Topiramate dosages in mg/day. The table categorizes results by partial-onset seizures in adults and pediatric patients, primary generalized tonic-clonic seizures, and Lennox-Gastaut syndrome, with footnotes on statistical comparisons and dosing details.*

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Tab14 (Table 14)

A data table summarizing the percent reduction from baseline to the last 12 weeks of the double-blind phase in average monthly attack rate from Study 13 (Intent-to-Treat Analysis Set). It compares Placebo, Topiramate 50 mg/day, and Topiramate 100 mg/day groups, showing median baseline values, last 12 weeks median values, and median percent reduction with associated p-values.*

* 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.