Pregabalin Capsule
Product Images NDC 71610-882

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-882). 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 50 mg (71610 0882 46)

Pregabalin 50 mg capsule label showing the product name, strength, and quantity of 56 capsules. The label includes storage instructions, manufacturer details (MSN Laboratories Private Limited, Telangana, India), and repackager information (Aphena Pharma Solutions, Tennessee). It displays a barcode, NDC number 71610-882-46, and warnings including 'Keep out of reach of children' and habit-forming potential.*

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Aphena Pharma Solutions (TN)

FDA Label Image

Equation (Pregabain Gault Equation)

The image displays a mathematical formula for calculating creatinine clearance (CLCr). The formula involves age, weight in kilograms, serum creatinine in mg/dL, and includes a correction factor for female patients (multiplied by 0.85). This is likely part of dosing or clinical guidance information related to Pregabalin capsules.*

FDA Label Image

Fig-01 (Pregabalin Figure 01)

A line graph showing percent of patients improved on the y-axis versus percent improvement in pain from baseline on the x-axis for different Pregabalin dosages and placebo. The graph compares Pregabalin 25 mg, 100 mg, and 200 mg taken three times a day against placebo, indicating varying degrees of pain improvement among patient groups.*

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Fig-02 (Pregabalin Figure 02)

A Kaplan-Meier plot showing the percent of patients improved versus percent improvement in pain from baseline. It compares patients taking Pregabalin 100 mg three times a day (dashed line) to those taking placebo (dotted line), depicting higher improvement rates with Pregabalin across pain improvement percentages.*

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Fig-03 (Pregabalin Figure 03)

A line graph showing percent improvement in pain from baseline (x-axis) against percent of patients improved (y-axis). It compares four groups: Pregabalin 300 mg twice daily, Pregabalin 150 mg twice daily, Pregabalin 75 mg twice daily, and Placebo. The solid line represents the highest dose, with diminishing percentages for lower doses, and the placebo as the lowest dotted line.*

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Fig-04 (Pregabalin Figure 04)

A line graph showing percent improvement in pain from baseline on the x-axis and percent of patients improved on the y-axis for Pregabalin at 200 mg three times a day, 100 mg three times a day, and placebo. The graph compares these three groups with labeled lines: solid for 200 mg, dashed for 100 mg, and dotted for placebo.*

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Fig-05 (Pregabalin Figure 05)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. The graph compares three groups: Pregabalin 100 mg three times a day (dashed line), Pregabalin 50 mg three times a day (solid line), and Placebo (dotted line). The y-axis represents the percent of patients improved, and the x-axis shows the percent improvement in pain from baseline, ranging from greater than 0% to 100%. Vertical lines mark increments on the x-axis at 10% intervals.*

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Fig-06 (Pregabalin Figure 06)

A bar chart showing responder rates (%) from two studies labeled E1 and E3. Study E1 compares placebo with Pregabalin doses of 50 mg, 150 mg, 300 mg, and 600 mg per day, showing increasing responder rates with higher doses. Study E3 compares placebo with 600 mg per day Pregabalin taken twice daily (BID) and three times daily (TID), with higher responder rates for TID dosing.*

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Fig-07 (Pregabalin Figure 07)

This is a line graph showing seizure reduction (median % change from baseline) on the vertical axis versus dose (mg/day) on the horizontal axis. Four dose regimens are plotted: Stukly E1BID, E2BID, E3BID, and E3TID, with data points at approximately 0, 50, 150, 300, and 600 mg/day. The graph shows increasing seizure reduction with higher doses, with p-values indicating statistically significant differences at various points.*

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Fig-09 (Pregabalin Figure 09)

A cumulative distribution plot comparing percent improvement in pain from baseline versus percent of patients improved for Pregabalin at daily doses of 600 mg, 450 mg, 300 mg, and placebo. The chart displays four curves representing each dose group, with percent improvement in pain on the horizontal axis and percent of patients improved on the vertical axis, ranging from 0% to 100%.*

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Fig-10 (Pregabalin Figure 10)

A Kaplan-Meier survival curve chart comparing Pregabalin to Placebo. The y-axis shows the estimated percentage of subjects without LTR, ranging from 0% to 100%. The x-axis represents time in days, from 0 to 180. The solid line represents Pregabalin, and the dashed line represents Placebo, illustrating differences in the proportion of subjects without LTR over time.*

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Fig-11 (Pregabalin Figure 11)

A line graph showing the percent of subjects improved on the vertical axis versus percent improved from baseline to week 12 BOCF on the horizontal axis. It compares Pregabalin and placebo, with Pregabalin represented by a solid line and placebo by a dashed line, illustrating a higher percent improvement for Pregabalin across the range.*

FDA Label Image

Fig-12 (Pregabalin Figure 12)

A Kaplan-Meier curve showing the percent of subjects improved over baseline to week 16 using BOCF method. The y-axis represents percent of subjects improved, ranging from 0 to 100%. The x-axis shows percent improved from baseline to week 16, with values from >0 to ≥100. Two lines are plotted: a solid line for Pregabalin and a dashed line for Placebo, illustrating comparative improvement rates over the study period.*

FDA Label Image

Str (Pregabalin Structure)

Chemical structure of pregabalin, showing its molecular arrangement including amino and carboxyl functional groups.*

* 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.