Pregabalin Capsule
Product Images NDC 71610-619

16 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-619). 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 150 mg (71610 0618 53)

Bottle Label 150 mg (71610 0618 53)
Pregabalin 150 mg capsules package label showing 60 capsules per container. The label includes the NDC number 71610-0618-53 and storage instructions between 20-25 degrees Celsius. Manufacturer is ScieGen Pharmaceuticals Inc., with repackaging by Aphena Pharma Solutions - Tennessee, LLC. The label displays warnings including potential habit forming and RX only status.*
FDA Label Image

Bottle Label 50 mg (71610 0619 53)

Bottle Label 50 mg (71610 0619 53)
Label for Pregabalin capsules, available in 50 mg strength. The package contains 60 capsules and is labeled for oral use. The label includes storage instructions, manufacturer and repackager information, and the NDC number 71610-0619-53. The product is prescription only and includes a warning about potential habit forming.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Pregabalin Fig01)

Figure 1 (Pregabalin Fig01)
A line graph showing percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin doses of 200 mg, 100 mg, and 25 mg three times a day, plus placebo. The graph uses different dashed lines for each treatment group, illustrating trends in pain improvement percentages.*
FDA Label Image

Figure 2 (Pregabalin Fig02)

Figure 2 (Pregabalin Fig02)
A line graph showing the percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin 100 mg three times a day to placebo. The graph depicts higher patient improvement percentages for Pregabalin across various pain improvement thresholds.*
FDA Label Image

Figure 3 (Pregabalin Fig03)

Figure 3 (Pregabalin Fig03)
A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin at doses of 300 mg, 150 mg, and 75 mg taken twice a day to a placebo. The x-axis shows percent improvement in pain, and the y-axis shows percent of patients improved.*
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Figure 4 (Pregabalin Fig04)

Figure 4 (Pregabalin Fig04)
A line graph showing the relationship between percent improvement in pain from baseline (x-axis) and percent of patients improved (y-axis) for Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph compares patient improvement percentages across different doses and placebo.*
FDA Label Image

Figure 5 (Pregabalin Fig05)

Figure 5 (Pregabalin Fig05)
A line graph comparing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The graph shows separate curves for each treatment and placebo, with improvement percentages on the y-axis and pain improvement percentages on the x-axis, marked at intervals including 30% and 50%.*
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Figure 6 (Pregabalin Fig06)

Figure 6 (Pregabalin Fig06)
A bar chart showing responder rates (%) from two clinical studies (E1 and E3) of Pregabalin at varying doses compared to placebo. Study E1 includes placebo, 50 mg/day, 150 mg/day, 300 mg/day, and 600 mg/day doses, while Study E3 compares placebo, 300 mg/day BID, and 600 mg/day TID doses. Statistically significant increases versus placebo are marked.*
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Figure 7 (Pregabalin Fig07)

Figure 7 (Pregabalin Fig07)
A line graph showing seizure reduction as median percentage change from baseline on the vertical axis versus dose in mg/day on the horizontal axis. The graph plots data points from four studies (E1 BD, E2 TID, E3 BD, E3 TID) at doses 0, 50, 150, 300, and 600 mg/day, indicating statistically significant seizure reduction at higher doses with p-values annotated near points.*
FDA Label Image

Figure 9 (Pregabalin Fig08)

Figure 9 (Pregabalin Fig08)
A line graph comparing percent improvement in pain from baseline against percent of patients improved for different daily doses of Pregabalin (300 mg, 450 mg, 800 mg) and placebo. The graph shows percent improvement on the x-axis from >0 to 100 and percent of patients improved on the y-axis from 0 to 100.*
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Figure 10 (Pregabalin Fig09)

Figure 10 (Pregabalin Fig09)
A Kaplan-Meier survival curve chart comparing Pregabalin and Placebo effects over 180 days. The y-axis shows the estimated percentage of subjects without LTR, and the x-axis shows days. Pregabalin is represented by a solid line, Placebo by a dashed line, demonstrating a higher percentage of subjects without LTR over time with Pregabalin.*
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Figure 11 (Pregabalin Fig10)

Figure 11 (Pregabalin Fig10)
A line graph comparing the percent of subjects improved from baseline to week 12 BOCF between Pregabalin and placebo. The x-axis shows percent improved ranges from 0 to 100, and the y-axis shows the percent of subjects improved. Pregabalin is represented by a solid line showing higher improvement percentages than the placebo, represented by a dotted line, across the improvement range.*
FDA Label Image

Figure 12 (Pregabalin Fig11)

Figure 12 (Pregabalin Fig11)
A line graph comparing the percent of subjects improved versus percent improvement from baseline to Week 16 for Pregabalin and Placebo. The solid line represents Pregabalin, showing higher improvement percentages across the range compared to the dotted line for Placebo. The y-axis shows percent of subjects improved, and the x-axis shows percent improvement from baseline.*
FDA Label Image

Cockcroft And Gault Equation (Pregabalin Formula)

Cockcroft And Gault Equation (Pregabalin Formula)
An equation calculating creatinine clearance (CLcr) based on age in years, weight in kilograms, and serum creatinine in mg/dL, including an adjustment factor of 0.85 for female patients. The formula is presented clearly in mathematical notation.*
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Chemical Structure (Pregabalin Str)

Chemical Structure (Pregabalin Str)
Chemical structure of the active ingredient Pregabalin, shown as a molecular diagram with labeled functional groups including amine (NH2) and carboxyl (CO2H) moieties.*

* 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.