Pregabalin Capsule
Product Images NDC 71610-997

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-997). 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 0997 30)

Pregabalin 200 mg capsule label shows the product name, strength, and quantity of 30 capsules. It includes the NDC number 71610-997-30, storage instructions, manufacturer as ScieGen Pharmaceuticals Inc, and the labeler as Aphena Pharma Solutions - Tennessee, LLC. Additional details include warnings and batch information.*

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Aphena (Aphena)

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Figure 1 (Pregabalin Fig01)

A line graph depicting the percent of patients improved plotted against percent improvement in pain from baseline. Four lines represent different groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, Pregabalin 25 mg three times a day, and placebo. The graph shows trends comparing the efficacy of varying Pregabalin doses to placebo.*

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Figure 2 (Pregabalin Fig02)

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 and placebo, illustrating patient response differences over various pain improvement thresholds.*

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Figure 3 (Pregabalin Fig03)

A line chart displaying the percent of patients improved relative to percent improvement in pain from baseline. It compares Pregabalin at doses of 75 mg, 150 mg, and 300 mg taken twice daily against a placebo group. Each group is represented by distinct lines showing patient response distribution across varying levels of pain improvement percentages.*

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Figure 4 (Pregabalin Fig04)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline for three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph shows higher improvement percentages for the Pregabalin 200 mg group compared to the 100 mg and placebo groups across the pain improvement scale.*

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Figure 5 (Pregabalin Fig05)

A line graph displaying percent improvement in pain from baseline on the x-axis against percent of patients improved on the y-axis. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo, using different line styles to distinguish each.*

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Figure 6 (Pregabalin Fig06)

A bar chart comparing responder rates (%) across dosages of pregabalin and placebo in two studies, E1 and E3. The x-axis shows treatment groups including placebo and various pregabalin dosages (50 mg/day to 600 mg/day). The y-axis represents the responder rate percentage. The chart highlights statistically significant differences versus placebo with asterisks.*

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Figure 7 (Pregabalin Fig07)

A line graph depicting seizure reduction as median percentage change from baseline across different doses (mg/day). It compares four study groups labeled Study E1 BD, Study E2 TID, Study E3 BD, and Study E3 TID, with statistical significance values annotated for various data points along the dose axis. The dose ranges from 0 to 600 mg/day, and the seizure reduction varies up to approximately 50%.*

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Figure 9 (Pregabalin Fig08)

A line graph showing percent of patients improved against percent improvement in pain from baseline for Pregabalin doses of 800 mg, 450 mg, 300 mg daily, and placebo. The graph compares treatment effects with four different curve styles representing each group over a 0 to 100 percent improvement range.*

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Figure 10 (Pregabalin Fig09)

A line graph comparing the estimated percentage of subjects without LTR over a period of 180 days between Pregabalin and placebo groups. The x-axis represents days, and the y-axis shows the estimated percentage of subjects without LTR, with Pregabalin displaying a higher percentage than placebo throughout the study.*

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Figure 11 (Pregabalin Fig10)

A line graph showing the percent of subjects improved from baseline to Week 12 for Pregabalin 200 mg capsules compared to placebo. The y-axis represents the percent of subjects improved, ranging from 0 to 100%, and the x-axis shows the percent improvement from baseline to Week 12 BOCF. The solid line represents Pregabalin, and the dotted line represents placebo, illustrating higher improvement rates with Pregabalin.*

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Figure 12 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved after treatment with Pregabalin versus placebo. The X-axis represents the percent improvement from baseline to week 16 BOCF, ranging from 0 to 100 percent. The Y-axis shows the percent of subjects improved, ranging from 0 to 100 percent. A solid line represents Pregabalin, and a dotted line represents placebo, showing a higher percent of subjects improved with Pregabalin across the improvement spectrum.*

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Figure 13 (Pregabalin Fig13)

A vertical bar chart comparing responder rates (%) for placebo and two dosage groups of a drug at 2.5 mg/kg/day and 10 mg/kg/day, with sample sizes shown below each group. The responder rate increases from 22.6% in the placebo group to 29.1% and 40.6% in the 2.5 mg/kg/day and 10 mg/kg/day groups, respectively.*

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Cockcroft And Gault Equation (Pregabalin Formula)

A formula showing the calculation for creatinine clearance (CLcr) as a function of age, weight, and serum creatinine, with an adjustment factor of 0.85 for female patients. The formula is presented as a text panel with variables and their units clearly indicated.*

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Chemical Structure (Pregabalin Str)

Chemical structure of pregabalin showing its molecular arrangement with a carboxylic acid group (CO2H) and an amine group (NH2) 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.