Pregabalin Capsule
Product Images NDC 71610-936

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-936). 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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Label (71610 0936 30)

Label for Pregabalin 100 mg oral capsules, containing 30 capsules per package. The label includes handling instructions to store between 20-25 degrees Celsius and dispense in a light-resistant container. Manufactured by SciGen Pharmaceuticals Inc., Hauppauge, NY, and repackaged by Aphena Pharma, Cookeville, TN. The label notes the product is for prescription use and includes warnings about potential habit forming.*

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Aphena (Aphena)

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Figure 1 (Pregabalin Fig01)

A cumulative distribution plot showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at doses of 200 mg, 100 mg, and 25 mg three times a day compared to placebo. The graph illustrates different improvement rates among the dosing groups and placebo.*

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Figure 2 (Pregabalin Fig02)

A line graph showing percent of patients improved on the vertical axis and percent improvement in pain from baseline on the horizontal axis. It compares Pregabalin 100 mg taken three times a day with placebo, using two distinct lines to represent each treatment group.*

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Figure 3 (Pregabalin Fig03)

A line graph depicting percent of patients improved versus percent improvement in pain from baseline for Pregabalin at doses of 75 mg, 150 mg, and 300 mg taken twice a day, compared with placebo. The y-axis shows percent of patients improved, and the x-axis shows percent improvement in pain from baseline, with vertical lines at 30% and 50% improvement.*

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Figure 4 (Pregabalin Fig04)

A line graph comparing the percent of patients improved versus the percent improvement in pain from baseline for Pregabalin 100 mg and 200 mg taken three times a day, and placebo. The graph shows three distinct curves, with Pregabalin 200 mg generally demonstrating higher patient improvement percentages across increasing pain improvement thresholds compared to Pregabalin 100 mg and placebo.*

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Figure 5 (Pregabalin Fig05)

A line graph showing percent of patients improved on the vertical axis against percent improvement in pain from baseline on the horizontal axis. The graph compares three groups: Pregabalin 100 mg three times a day (dashed line), Pregabalin 50 mg three times a day (solid line), and placebo (dotted line), showing trends of increasing patient improvement with higher doses of Pregabalin compared to placebo.*

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Figure 6 (Pregabalin Fig06)

A bar chart depicting responder rates (%) from two clinical studies, E1 and E3. The x-axis shows dosages including placebo and various daily amounts of the drug, while the y-axis shows responder rates from 0% to 60%. Bars illustrate responses increasing with higher doses in both studies, with some bars marked as statistically significant versus placebo.*

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Figure 7 (Pregabalin Fig07)

A dose-response line graph depicting seizure reduction as median percent change from baseline versus pregabalin dose (mg/day). It includes four study groups with significant p-values denoted for different doses. The graph shows seizure reduction increases with dose across studies E1, E2, and E3 with BID and TID dosing.*

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Figure 9 (Pregabalin Fig08)

A line chart showing percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin doses of 800 mg, 450 mg, 300 mg daily, and placebo. The vertical axis represents percent of patients improved, and the horizontal axis represents percent improvement in pain from baseline, with multiple vertical reference lines.*

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Figure 10 (Pregabalin Fig09)

A Kaplan-Meier survival curve chart comparing the estimated percentage of subjects without LTR (loss to response) over 180 days for Pregabalin versus Placebo. The graph shows a higher percentage of subjects without LTR in the Pregabalin group compared to Placebo throughout the study period.*

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Figure 11 (Pregabalin Fig10)

A line graph comparing the percent of subjects improved over a range of percentage improvements from baseline to week 12 for Pregabalin and Placebo. The x-axis shows the percent improved from baseline to week 12, and the y-axis shows the percent of subjects improved. Two lines represent Pregabalin (solid line) and Placebo (dashed line), illustrating greater improvement in the Pregabalin group across the range.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing percent of subjects improved between Pregabalin and Placebo groups. The x-axis shows percent improved from baseline to week 16 BOCF, ranging 0 to 100%; the y-axis shows percent of subjects improved from 0 to 100%. The solid line represents Pregabalin, and the dotted line represents Placebo. The graph illustrates higher improvement rates for Pregabalin across most percentages.*

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Figure 13 (Pregabalin Fig13)

A vertical bar chart showing responder rates (%) for three groups: Placebo (22.6%), 2.5 mg/kg/day (29.1%), and 10 mg/kg/day (40.6%). The x-axis labels the groups with sample sizes (N=93, 103, and 96 respectively) while the y-axis represents the responder rate percentage from 0 to 60%.*

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Cockcroft And Gault Equation (Pregabalin Formula)

A formula showing how to calculate creatinine clearance (CLcr), using age, weight, serum creatinine, and a factor for female patients (0.85). The formula divides (140 minus age in years) times weight in kg by 72 times serum creatinine in mg/dL, with multiplication by 0.85 for females.*

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Chemical Structure (Pregabalin Str)

Chemical structure diagram of pregabalin, showing the molecular arrangement associated with the active ingredient Pregabalin.*

* 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.