Pregabalin Capsule
Product Images NDC 53401-007

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 53401-007). 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 (53401 0007 30)

Label for Pregabalin 50 mg capsules, showing a package containing 30 capsules. The label includes the NDC number 53401-007-30 and the labeler as Aphena Pharma Solutions - Tennessee, LLC, located in Cookeville, TN. Storage and dispensing instructions are included, with warnings to keep out of reach of children.*

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Aphena (Aphena)

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Figure 1 (Pregabalin Fig01)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares four groups: Pregabalin 200 mg three times a day, 100 mg three times a day, 25 mg three times a day, and placebo, with distinct line styles for each group.*

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Figure 2 (Pregabalin Fig02)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline comparing Pregabalin 100 mg three times a day and placebo. The x-axis represents percent improvement in pain, and the y-axis represents percent of patients improved, with two lines demonstrating higher improvement for Pregabalin than placebo.*

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Figure 3 (Pregabalin Fig03)

A line graph showing percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin at 300 mg, 150 mg, and 75 mg taken two times a day, against placebo. The x-axis represents percent improvement in pain, and the y-axis shows percent of patients improved.*

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Figure 4 (Pregabalin Fig04)

A line graph showing the percentage 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 placebo. The graph compares efficacy across these groups with the x-axis representing percent improvement in pain and the y-axis the percent of patients improved.*

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Figure 5 (Pregabalin Fig05)

A line graph depicting 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, illustrating differences in patient pain improvement response rates.*

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Figure 6 (Pregabalin Fig06)

A bar chart comparing responder rates (%) across different dosages of pregabalin in two clinical studies, labeled Study E1 and Study E3. The x-axis shows treatment groups including placebo and various pregabalin dosages, while the y-axis measures responder rate from 0% to 60%. Statistical significance versus placebo is indicated with asterisks.*

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Figure 7 (Pregabalin Fig07)

A graph showing median percentage change in seizure reduction from baseline versus dose in mg/day. The chart compares four study groups: Study E1 BD, Study E2 TID, Study E3 BD, and Study E3 TID, with significant p-values indicated for several dose levels. Dose ranges displayed include 0, 50, 150, 300, and 600 mg/day.*

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Figure 9 (Pregabalin Fig08)

A line graph depicting the percent of patients improved based on percent improvement in pain from baseline for Pregabalin doses of 300 mg, 450 mg, 800 mg daily, and placebo. The x-axis shows percent improvement in pain increments from 0 to 100, and the y-axis shows the percent of patients improved from 0 to 100. Four lines represent different doses and placebo responses over the improvement range.*

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Figure 10 (Pregabalin Fig09)

A survival curve chart comparing the percentage of subjects without LTR over a period of 180 days between Pregabalin and placebo groups. The y-axis shows the estimated percentage of subjects without LTR from 0% to 100%, and the x-axis shows days from 0 to 180. The solid line represents Pregabalin, and the dashed line represents placebo, with Pregabalin maintaining a higher percentage of subjects without LTR over time.*

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Figure 11 (Pregabalin Fig10)

A line graph showing the percent of subjects improved plotted against the percent improvement from baseline to week 12 BOCF. The graph compares Pregabalin with Placebo, with Pregabalin represented by a solid line showing higher improvement percentages than the Placebo, which is represented by a dotted line.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved between Pregabalin and placebo groups over a range of percent improvement from baseline to week 16 BOCF. The x-axis shows percent improvement from 0 to 100, and the y-axis shows the percent of subjects improved from 0 to 100. Pregabalin is represented by a solid line and placebo by a dotted line, with Pregabalin showing higher improvement percentages across most of the range.*

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Figure 13 (Pregabalin Fig13)

A bar graph showing responder rates (%) for Pregabalin at different dosages compared to placebo. The x-axis lists Placebo, 2.5 mg/kg/day, and 10 mg/kg/day groups with respective sample sizes. The y-axis shows responder rates, with 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 formula for calculating creatinine clearance (CLcr) based on age, weight, and serum creatinine, including an adjustment factor of 0.85 for female patients. The calculation uses age in years, weight in kilograms, and serum creatinine in mg/dL.*

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Chemical Structure (Pregabalin Str)

Chemical structure of pregabalin, showing its molecular arrangement including an amino group (NH2), carboxyl group (CO2H), and a branched aliphatic side 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.