Pregabalin Capsule
Product Images NDC 71610-995

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-995). 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 0995 30)

Label for Pregabalin 225 mg oral capsules, packaged as 30 capsules. The label includes storage instructions, manufacturer information (ScieGen Pharmaceuticals Inc, Hauppauge, NY), and packager details (Aphena Pharma, Cookeville, TN). It also notes that the product is prescription only and may be habit forming.*

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Aphena (Aphena)

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Figure 1 (Pregabalin Fig01)

A line graph depicting percent improvement in pain from baseline on the x-axis and percent of patients improved on the y-axis for Pregabalin at 225 mg doses three times a day compared to placebo. It shows distinct curves for Pregabalin at 25 mg, 100 mg, and 200 mg three times daily, and placebo, illustrating varying degrees of patient-reported pain improvement.*

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Figure 2 (Pregabalin Fig02)

A line graph showing the percent of patients improved on the vertical axis versus percent improvement in pain from baseline on the horizontal axis. The graph compares Pregabalin 100 mg taken three times a day with a placebo, illustrating patient improvement percentages across pain reduction ranges.*

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Figure 3 (Pregabalin Fig03)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin at 300 mg, 150 mg, and 75 mg taken twice daily to placebo, with higher doses generally showing greater improvement.*

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Figure 4 (Pregabalin Fig04)

A line graph comparing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at 200 mg three times a day, Pregabalin at 100 mg three times a day, and a placebo. The graph shows three distinct decreasing curves representing these groups on the axes of percent improvement in pain (x-axis) and percent of patients improved (y-axis).*

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Figure 5 (Pregabalin Fig05)

A line graph comparing the percent of patients improved with Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo, plotted against percent improvement in pain from baseline. The vertical axis shows the percent of patients improved, and the horizontal axis shows the percent improvement in pain.*

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Figure 6 (Pregabalin Fig06)

A bar chart presenting responder rates (%) from two clinical studies, Study E1 and Study E3, comparing placebo and varying dosages of pregabalin. The x-axis shows treatment groups with dosage details and the y-axis displays the responder rate percentage. Study E1 includes placebo, 50 mg/day, 150 mg/day, 300 mg/day, and 600 mg/day, while Study E3 includes placebo, 300 mg/day, and 600 mg/day. Statistically significant differences versus placebo are noted with asterisks.*

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Figure 7 (Pregabalin Fig07)

A line graph showing seizure reduction as median percentage change from baseline versus dose (mg/day) for Pregabalin studies. Four study groups (E1 BD, E2 TID, E3 BD, E3 TID) are marked with different symbols, each demonstrating increasing seizure reduction with higher doses up to 600 mg/day. Significant p-values are noted for each data point.*

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Figure 9 (Pregabalin Fig08)

A Kaplan-Meier plot showing the percent of patients improved on the y-axis versus percent improvement in pain from baseline on the x-axis. The graph compares Pregabalin at 800 mg, 450 mg, and 300 mg daily doses to placebo, represented by different line styles, demonstrating patient improvement over varying pain reduction percentages.*

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Figure 10 (Pregabalin Fig09)

A Kaplan-Meier survival curve graph depicting the estimated percentage of subjects without LTR (lost to response) over 180 days, comparing Pregabalin and placebo groups. The graph shows a higher percentage of subjects without LTR in the Pregabalin group (solid line) compared to the placebo group (dashed line) throughout the observed period.*

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Figure 11 (Pregabalin Fig10)

A line graph comparing the percent of subjects improved from baseline to week 12 using the BOCF method for Pregabalin versus Placebo. The x-axis represents percent improvement from greater than 0 to 100, and the y-axis shows the percent of subjects improved. Pregabalin shows a consistently higher improvement rate than Placebo across the range.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing the percentage of subjects improved from baseline to week 16 based on percent improvement. The x-axis represents percent improvement from 0 to 100, and the y-axis shows the percentage of subjects improved. Two lines are displayed: a solid line for Pregabalin and a dashed line for Placebo, illustrating higher improvement percentages with Pregabalin across the range.*

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Figure 13 (Pregabalin Fig13)

A bar chart depicting responder rates (%) for three groups: Placebo with 22.6%, 2.5 mg/kg/day with 29.1%, and 10 mg/kg/day with 40.6%. The number of subjects (N) is shown below each group: 93 for Placebo, 103 for 2.5 mg/kg/day, and 96 for 10 mg/kg/day.*

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Cockcroft And Gault Equation (Pregabalin Formula)

A mathematical formula for calculating creatinine clearance (CLcr), which includes variables for age (years), weight (kg), and serum creatinine (mg/dL), with an adjustment factor of 0.85 for female patients, shown as a fraction.*

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Chemical Structure (Pregabalin Str)

Chemical structure of pregabalin, showing its molecular formula with an amino group (NH2) and carboxyl group (CO2H) attached to a branched carbon chain.*

* 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.