Pregabalin Capsule
Product Images NDC 71610-887

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-887). 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.

FDA Label Image

Bottle Label 300 mg (71610 0887 30)

Label for Pregabalin 300 mg oral capsules, containing 30 capsules per package. The label includes storage instructions to keep between 20-25 degrees Celsius and a warning to keep out of reach of children. Manufacturer information lists MSN Laboratories Private Limited, Telangana, India, with repackaging by Aphena Pharma, Cookeville, TN. The label also states RX only and notes the product as human prescription drug.*

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Aphena Pharma Solutions (TN)

FDA Label Image

Equation (Pregabain Gault Equation)

A formula panel showing the creatinine clearance (CLCr) calculation including variables age, weight in kilograms, serum creatinine in mg/dL, and a factor for female patients (0.85). The text appears to be part of dosing or clinical guidance for Pregabalin capsules 300 mg by Aphena Pharma Solutions - Tennessee, LLC.*

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Fig-01 (Pregabalin Figure 01)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at different dosages and placebo. Four lines represent Pregabalin 200 mg three times a day, 100 mg three times a day, 25 mg three times a day, and placebo, showing varying levels of patient improvement.*

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Fig-02 (Pregabalin Figure 02)

A line graph showing percent of patients improved versus percent improvement in pain from baseline. Two lines compare Pregabalin 100 mg three times a day (dashed line) with placebo (dotted line), illustrating patient response rates at various thresholds of pain improvement.*

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Fig-03 (Pregabalin Figure 03)

A line chart depicting the percent of patients improved versus percent improvement in pain from baseline for Pregabalin oral capsules in doses of 75 mg, 150 mg, and 300 mg taken two times a day, compared to placebo. The chart shows patient response rates decreasing as the percent improvement in pain increases across all groups.*

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Fig-04 (Pregabalin Figure 04)

A Kaplan-Meier curve chart depicting the percent of patients improved in pain from baseline by percent improvement categories. The chart compares Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo groups, showing the distribution of patient response rates for pain improvement.*

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Fig-05 (Pregabalin Figure 05)

A line graph showing percent of patients improved versus percent improvement in pain from baseline for Pregabalin. It compares Pregabalin 100 mg three times a day (dashed line), Pregabalin 50 mg three times a day (solid line), and placebo (dotted line). The graph indicates higher patient improvement percentages for Pregabalin doses compared to placebo across various pain improvement thresholds.*

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Fig-06 (Pregabalin Figure 06)

A bar graph showing responder rates (%) from two clinical studies, labeled Study E1 and Study E3, with various dosages of Pregabalin and placebo. The X-axis lists dose groups with dosing schedules (BID, TID), and the Y-axis shows responder rate percentages. Study E1 compares placebo and Pregabalin at doses from 50 mg to 600 mg per day (BID). Study E3 compares placebo with 600 mg per day doses given BID and TID. The graph includes sample sizes per group and indicates statistically significant differences from placebo.*

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Fig-07 (Pregabalin Figure 07)

A line graph showing seizure reduction as median percentage change from baseline versus dose in mg/day. Four data series (Stukly E1BID, E2BID, E3BID, and E3TID) are plotted with dotted lines, indicating seizure reduction increases with dose from 0 to 600 mg/day. Significant p-values are annotated at several points on the curves.*

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Fig-09 (Pregabalin Figure 09)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin doses of 300 mg, 450 mg, and 600 mg daily compared to placebo. The graph includes four lines representing each dose and placebo, depicting patient response distribution across a range of pain improvement percentages from 0% to 100%.*

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Fig-10 (Pregabalin Figure 10)

A Kaplan-Meier curve chart comparing Pregabalin and placebo treatments. The x-axis represents days from 0 to 180, and the y-axis shows the estimated percentage of subjects without LTR from 0% to 100%. The solid line shows Pregabalin, and the dashed line shows placebo, indicating differences in subject outcomes over time.*

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Fig-11 (Pregabalin Figure 11)

A survival curve chart displaying the percent of subjects improved over time from baseline to week 12 using Baseline Observation Carried Forward (BOCF). The X-axis represents percent improved, and the Y-axis shows the percent of subjects improved. Two lines compare Pregabalin and Placebo, with Pregabalin showing a higher percentage of subjects improved across improvement thresholds.*

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Fig-12 (Pregabalin Figure 12)

A line chart comparing the percent of subjects improved over time from baseline to week 16 using Baseline Observation Carried Forward (BOCF). The y-axis represents the percent of subjects improved (0% to 100%), and the x-axis shows percent improved from baseline to week 16. Two lines are shown: one solid line for Pregabalin and one dashed line for Placebo, depicting a higher percent of subjects improved with Pregabalin compared to Placebo.*

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Str (Pregabalin Structure)

Chemical structure of Pregabalin, showing its molecular composition with an amino group, carboxylic acid group, and a branched alkyl 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.