Pregabalin Capsule
Product Images NDC 71610-800

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-800). 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 0800 30)

Pregabalin 300 mg capsule label showing a package containing 30 capsules. The label includes storage instructions to keep the product between 20-25 degrees Celsius, protect from light, avoid freezing, and keep out of reach of children. It is manufactured by ScieGen Pharmaceuticals Inc., distributed by Aphena Pharma Solutions - Tennessee, LLC. The label includes the product NDC 71610-0800-30 and barcodes for scanning.*

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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. It shows four lines representing different treatment groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, Pregabalin 25 mg three times a day, and a placebo group, illustrating patient response rates across a range of pain improvement percentages.*

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Figure 2 (Pregabalin Fig02)

A line graph comparing percent improvement in pain from baseline versus percent of patients improved for Pregabalin 100 mg three times a day and placebo. The vertical axis shows percent of patients improved, and the horizontal axis shows percent improvement in pain from baseline, with both lines depicting the treatment and placebo responses across the range.*

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Figure 3 (Pregabalin Fig03)

A line graph depicting the percentage of patients improved against percent improvement in pain from baseline for various treatments: Pregabalin 300 mg, 150 mg, and 75 mg taken twice a day, and placebo. The graph shows trends for pain improvement at different thresholds on the x-axis, with percentage of patients improved on the y-axis.*

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Figure 4 (Pregabalin Fig04)

A line graph showing the percent of patients improved versus 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 patient response levels at various pain improvement percentages.*

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Figure 5 (Pregabalin Fig05)

A line graph showing percent of patients improved versus percent improvement in pain from baseline for three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The graph illustrates a higher percentage of improved patients with Pregabalin compared to placebo across various pain improvement levels.*

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Figure 6 (Pregabalin Fig06)

A bar chart comparing responder rates (%) across different dosages of Pregabalin versus placebo in two studies, E1 and E3. Study E1 shows increasing responder rates from placebo to 600 mg/day BID dosing, with 600 mg/day BID reaching 51%. Study E3 shows rates for placebo and Pregabalin at 300 mg/day BID and 600 mg/day TID, with a maximum responder rate of 49%. Bars are annotated for statistical significance versus placebo.*

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Figure 7 (Pregabalin Fig07)

A line graph showing seizure reduction as the median percentage change from baseline plotted against dose in mg/day for different studies labeled E1, E2, and E3 with BD and TID dosing regimens. The graph includes significance p-values for data points and shows dose-dependent increases in seizure reduction up to 600 mg/day.*

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Figure 9 (Pregabalin Fig08)

A line graph depicting the percent of patients improved against percent improvement in pain from baseline for Pregabalin at daily doses of 300 mg, 450 mg, 800 mg, and placebo. The graph shows comparative trends for each dose over a 0 to 100 percent improvement range.*

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Figure 10 (Pregabalin Fig09)

A Kaplan-Meier survival curve comparing the estimated percentage of subjects without LTR (loss to response) over 180 days for Pregabalin versus placebo. The plot shows the x-axis as Days (0 to 180) and the y-axis as the Estimated Percentage of Subjects without LTR (0% to 100%). The solid line represents Pregabalin, and the dashed line represents placebo, illustrating differences in subject outcomes over time.*

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Figure 11 (Pregabalin Fig10)

A line chart comparing the percent of subjects improved over baseline to week 12 between Pregabalin and placebo groups. The x-axis shows percent improvement from baseline, ranging from 0 to 100, and the y-axis displays percent of subjects improved from 0 to 100. Solid line represents Pregabalin, showing consistently higher improvement rates than the dashed line for placebo.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to week 16 BOCF between Pregabalin and placebo groups. The x-axis represents percent improved, while the y-axis shows percent of subjects improved. Two lines illustrate the difference in outcomes for Pregabalin (solid line) versus placebo (dashed line).*

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Figure 13 (Pregabalin Fig13)

A bar chart depicting responder rates as percentages for three groups: Placebo (22.6%, n=93), 2.5 mg/kg/day dosage (29.1%, n=103), and 10 mg/kg/day dosage (40.6%, n=96). The y-axis shows the responder rate percentage from 0 to 60%. The x-axis lists the three groups with sample sizes below.*

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Cockcroft And Gault Equation (Pregabalin Formula)

A formula depicting the calculation of creatinine clearance (CLcr) based on age, weight, serum creatinine, and a gender adjustment factor for female patients. The formula involves age in years, weight in kilograms, serum creatinine in mg/dL, and a multiplication factor of 0.85 for females.*

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Chemical Structure (Pregabalin Str)

Chemical structure of Pregabalin, showing its molecular formula as a branched chain with an amino group and a carboxylic acid group attached to the carbon backbone.*

* 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.