Pregabalin Capsule
Product Images NDC 71610-677

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-677). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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.

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Bottle Label 75 mg (71610 0677 30)

Pregabalin 75 mg capsules label showing packaging details for 30 capsules. The label includes storage instructions to keep at 20-25 degrees Celsius, a caution to keep out of reach of children, and a warning that may be habit forming. The labeler is Aphena Pharma Solutions - Tennessee, LLC, and the manufacturer is ScicGen Pharmaceuticals Inc. The product NDC on the label is 71610-0677-30.*

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Aphena Pharma Solutions (TN)

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Figure 1 (Pregabalin Fig01)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin dosed at 25 mg, 100 mg, and 200 mg three times a day versus placebo, illustrating trends in patient pain improvement at varying dose levels.*

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Figure 2 (Pregabalin Fig02)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin 100 mg three times a day with placebo, showing two curves representing patient improvement rates over varying levels of pain reduction.*

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Figure 3 (Pregabalin Fig03)

A line chart comparing percent improvement in pain from baseline to percent of patients improved for Pregabalin at doses of 75 mg, 150 mg, 300 mg taken twice a day, and placebo. The graph shows increasing percentages of pain improvement corresponding to different thresholds, with Pregabalin 300 mg twice a day showing the highest patient improvement rates.*

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Figure 4 (Pregabalin Fig04)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline. It compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, illustrating the relative improvement in pain across different levels of percentage improvement.*

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Figure 5 (Pregabalin Fig05)

A line graph comparing percent improvement in pain from baseline with percent of patients improved. It includes three lines showing results for Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and a placebo group. The x-axis represents percent improvement in pain, and the y-axis represents percent of patients improved.*

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Figure 6 (Pregabalin Fig06)

A bar chart comparing responder rates (%) across different doses of pregabalin in two separate studies, E1 and E3. For Study E1, doses range from 50mg/day to 600mg/day with escalating responder rates from 15% to 51%, all marked statistically significant versus placebo. For Study E3, 300mg/day and 600mg/day doses show increased responder rates of 43% and 49%, respectively, compared to placebo rates of 9%. The chart emphasizes the efficacy of various pregabalin doses relative to placebo.*

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Figure 7 (Pregabalin Fig07)

A dose-response chart showing seizure reduction as median percent change from baseline versus dose in mg/day. The chart compares four studies labeled E1 BD, E2 TID, E3 BD, and E3 TID, with data points indicating significant p-values. The Y-axis represents seizure reduction percentage up to 60%, and the X-axis shows dose ranging from 0 to 600 mg/day. Legend identifies each study with different symbols.*

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Figure 9 (Pregabalin Fig08)

A line chart showing percent improvement in pain from baseline on the x-axis and percent of patients improved on the y-axis. Four curves represent different treatments: Pregabalin 800 mg daily dose, 450 mg daily dose, 300 mg daily dose, and placebo, illustrating patient response distributions across varying doses compared to placebo.*

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Figure 10 (Pregabalin Fig09)

A Kaplan-Meier curve comparing the estimated percentage of subjects without LTR (Loss to Response) over 180 days between Pregabalin and placebo groups. The y-axis represents the estimated percentage of subjects without LTR, ranging from 0% to 100%, and the x-axis represents time in days from 0 to 180. The Pregabalin group shows a higher percentage of subjects without LTR over time compared to the placebo group.*

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Figure 11 (Pregabalin Fig10)

A line graph comparing the percent of subjects improved over a range of improvement percentages from baseline to week 12 for Pregabalin 75 mg capsules versus placebo. The y-axis represents the percent of subjects improved, and the x-axis represents the percent improved from baseline to week 12 using BOCF method. The solid line shows Pregabalin consistently higher than the dashed placebo line across improvement percentages.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved for Pregabalin versus Placebo. The x-axis represents the percent improvement from baseline to Week 16 on the BOCF scale, ranging from 0 to 100%. The y-axis shows the percent of subjects improved, from 0 to 100%. Two lines are shown: a solid line for Pregabalin and a dotted line for Placebo, with Pregabalin consistently having a higher percent of subjects improved.*

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Cockcroft And Gault Equation (Pregabalin Formula)

A mathematical formula calculating creatinine clearance (CLcr) based on age in years, weight in kilograms, serum creatinine in mg/dL, and adjusting by a factor of 0.85 for female patients.*

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Chemical Structure (Pregabalin Str)

Chemical structure of pregabalin, showing the arrangement of its molecular components including an amino group, carboxyl group, and hydrocarbon side chains.*

* 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.