Pregabalin Capsule
Product Images NDC 71610-999

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-999). 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 0999 30)

Pregabalin 75 mg capsule label showing a package of 30 capsules. The label includes the NDC number 71610-999-30, storage instructions, manufacturer information (ScienGen Pharmaceuticals Inc., Hauppauge, NY), and repackager information (Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN). Additional details include a control warning, prescription-only status, and batch information.*

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Aphena (Aphena)

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Figure 1 (Pregabalin Fig01)

A line graph illustrating the percent of patients improved versus percent improvement in pain from baseline for Pregabalin taken at 25 mg, 100 mg, and 200 mg three times a day, compared to placebo. The x-axis shows percent improvement in pain, while the y-axis shows percent of patients improved, with lines indicating dose response trends.*

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Figure 2 (Pregabalin Fig02)

A line chart displaying percent of patients improved versus percent improvement in pain from baseline. It compares two groups: one treated with Pregabalin 100 mg three times a day and a placebo group. The chart shows a higher percentage of patient improvement for Pregabalin compared to placebo across different levels of pain improvement.*

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Figure 3 (Pregabalin Fig03)

A line graph showing the percent of patients improved relative to percent improvement in pain from baseline for Pregabalin at 75 mg, 150 mg, and 300 mg dosed twice a day, compared to placebo. The x-axis represents percent improvement in pain, and the y-axis shows the percent of patients improved, with distinct lines for each dose and placebo.*

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Figure 4 (Pregabalin Fig04)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. Three lines compare Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, illustrating patient response rates across varying levels of pain improvement.*

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Figure 5 (Pregabalin Fig05)

A line chart showing percent of patients improved versus percent improvement in pain from baseline. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The vertical axis shows percent of patients improved (0 to 100%), and the horizontal axis shows percent improvement in pain from baseline (0 to 100%).*

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Figure 6 (Pregabalin Fig06)

A bar graph comparing responder rates (%) in two studies, Study E1 and Study E3, for different doses of Pregabalin versus placebo. Study E1 shows increasing responder rates from placebo to 600 mg/day with BID dosing, while Study E3 compares placebo with 300 mg/day BID and 600 mg/day TID. Statistically significant differences versus placebo are marked with an asterisk. Sample sizes (N) for each group are indicated below the x-axis.*

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Figure 7 (Pregabalin Fig07)

A dose-response chart showing seizure reduction (median % change from baseline) on the y-axis versus dose in mg/day on the x-axis. The graph compares four studies (E1 BD, E2 TID, E3 BD, E3 TID) represented by different markers. Levels of statistical significance (p-values) are noted for various dose points, with placebo dose indicated at zero mg/day. The chart highlights seizure reduction outcomes at different dosing regimens.*

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Figure 9 (Pregabalin Fig08)

A line chart showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares four groups: Pregabalin 800 mg daily dose, 450 mg daily dose, 300 mg daily dose, and placebo. Each group is represented by a distinct line style to differentiate the data curves.*

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Figure 10 (Pregabalin Fig09)

A Kaplan-Meier survival curve graph comparing Pregabalin and Placebo over 180 days. The vertical axis shows the estimated percentage of subjects without LTR (loss to response), and the horizontal axis represents days. The solid line represents Pregabalin, showing higher percentages without LTR over time compared to the dashed Placebo line.*

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Figure 11 (Pregabalin Fig10)

A line graph comparing percent of subjects improved from baseline to week 12 for Pregabalin versus placebo. The X-axis represents percent improved, ranging from 0 to 100, while the Y-axis shows the percent of subjects improved, also ranging from 0 to 100. The solid line shows higher improvement rates for Pregabalin compared to the dashed line for placebo.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved from baseline to week 16 using BOCF, showing two datasets labeled Pregabalin (solid line) and Placebo (dashed line). The x-axis represents percent improvement from 0 to 100, and the y-axis shows the percent of subjects improved from 0 to 100. The graph illustrates higher improvement percentages for Pregabalin compared to Placebo across the range.*

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Figure 13 (Pregabalin Fig13)

A bar chart illustrating responder rate percentages for Pregabalin at different dosages compared to placebo. The chart shows responder rates for placebo, 2.5 mg/kg/day, and 10 mg/kg/day groups, with sample sizes of 93, 103, and 96 respectively. Responder rates are approximately 22.6% for placebo, 29.1% for 2.5 mg/kg/day, and 40.6% for 10 mg/kg/day.*

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Cockcroft And Gault Equation (Pregabalin Formula)

A mathematical formula for calculating creatinine clearance (CLcr), incorporating age in years, weight in kilograms, serum creatinine in mg/dL, with an adjustment multiplier of 0.85 for female patients. This is likely part of dosing or pharmacokinetic information related to Pregabalin capsules.*

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Chemical Structure (Pregabalin Str)

Chemical structure diagram of pregabalin showing its molecular configuration including an amino group and a carboxyl group 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.