Pregabalin Capsule
Product Images NDC 55700-827

14 FDA label images from Quality Care Products, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 55700-827). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Quality Care Products, 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

Image Description (New Doc 2020 01 30 08.39.14 1)

Image Description (New Doc 2020 01 30 08.39.14 1)
Label for Pregabalin capsules 25 mg, a human prescription drug by Quality Care Products, LLC. The package contains 90 capsules and includes storage and warning information. Manufacturer is ScieGen Pharmaceuticals, Inc., Hauppauge, NY. The label displays GTIN and NDC codes, with a warning that the drug may be habit forming, and notes it is Rx only.*
FDA Label Image

Figure 1 (Pregabalin Fig01)

Figure 1 (Pregabalin Fig01)
A line graph showing percent improvement in pain from baseline on the x-axis versus percent of patients improved on the y-axis. 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 compares pain improvement responses among these groups.*
FDA Label Image

Figure 2 (Pregabalin Fig02)

Figure 2 (Pregabalin Fig02)
A line chart comparing percent improvement in pain from baseline with lines for Pregabalin 100 mg three times a day and placebo. The x-axis represents percent improvement in pain, while the y-axis shows the percent of patients improved. The chart visually depicts higher improvement percentages for the Pregabalin group relative to placebo across the range.*
FDA Label Image

Figure 3 (Pregabalin Fig03)

Figure 3 (Pregabalin Fig03)
A line graph showing percent of patients improved on the vertical axis versus percent improvement in pain from baseline on the horizontal axis. Four lines compare Pregabalin dosed at 75 mg, 150 mg, and 300 mg twice a day, and a placebo group, illustrating pain improvement across these groups.*
FDA Label Image

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). It compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph illustrates higher patient improvement percentages with the 200 mg dosage compared to the 100 mg and placebo.*
FDA Label Image

Figure 5 (Pregabalin Fig05)

Figure 5 (Pregabalin Fig05)
A line graph showing percent of patients improved versus percent improvement in pain from baseline, comparing Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The graph depicts decreasing percentages of patients improved as pain improvement thresholds increase, with Pregabalin treatments showing higher improvement rates than placebo.*
FDA Label Image

Figure 6 (Pregabalin Fig06)

Figure 6 (Pregabalin Fig06)
Bar chart comparing responder rates (%) across different dosage groups and placebo in two clinical studies, Study E1 and Study E3. The X-axis shows dose groups including placebo, 50 mg/day, 150 mg/day, 300 mg/day, and 600 mg/day with BID or TID dosing. The Y-axis shows responder rates from 0% to 60%. Higher doses show increased responder rates compared to placebo, with statistical significance noted.*
FDA Label Image

Figure 7 (Pregabalin Fig07)

Figure 7 (Pregabalin Fig07)
A line graph showing seizure reduction (median % change from baseline) on the vertical axis and dose (mg/day) on the horizontal axis. The graph compares seizure reduction across four studies (E1 BD, E2 TID, E3 BD, E3 TID) with different dosing regimens, highlighting statistically significant p-values at various dose levels up to 600 mg/day.*
FDA Label Image

Figure 9 (Pregabalin Fig08)

Figure 9 (Pregabalin Fig08)
A line chart showing percent improvement in pain from baseline on the x-axis and percent of patients improved on the y-axis, comparing the effects of Pregabalin at 800 mg, 450 mg, 300 mg daily doses versus placebo. The chart uses solid, dashed, and dotted lines to distinguish the groups.*
FDA Label Image

Figure 10 (Pregabalin Fig09)

Figure 10 (Pregabalin Fig09)
A line graph comparing the estimated percentage of subjects without LTR (loss of therapeutic response) over 180 days for Pregabalin versus Placebo. The y-axis shows the estimated percentage of subjects without LTR from 0% to 100%, and the x-axis shows the days from 0 to 180. The Pregabalin group consistently shows a higher percentage of subjects without LTR than the Placebo group over time.*
FDA Label Image

Figure 11 (Pregabalin Fig10)

Figure 11 (Pregabalin Fig10)
A line graph showing the percent of subjects improved over time from baseline to week 12, comparing Pregabalin and Placebo. The x-axis represents percent improved from baseline to week 12 BOCF, ranging from 0 to 100. The y-axis shows the percent of subjects improved, also from 0 to 100. The solid line indicates results for Pregabalin, and the dashed line represents Placebo, with Pregabalin showing a higher percentage of subjects improved across the range.*
FDA Label Image

Figure 12 (Pregabalin Fig11)

Figure 12 (Pregabalin Fig11)
A line graph depicting the percent of subjects improved from baseline to week 16 based on BOCF. The x-axis shows percent improvement from 0 to 100, and the y-axis shows the percent of subjects improved. Two lines compare Pregabalin and Placebo, with Pregabalin consistently showing higher percentages of subjects improved across the range.*
FDA Label Image

Cockcroft And Gault Equation (Pregabalin Formula)

Cockcroft And Gault Equation (Pregabalin Formula)
A pharmacokinetic formula calculating creatinine clearance (CLcr) based on age, weight, and serum creatinine, with an adjustment factor for female patients.*
FDA Label Image

Chemical Structure (Pregabalin Str)

Chemical Structure (Pregabalin Str)
Chemical structure diagram of the active ingredient pregabalin, showing its molecular configuration as depicted in the image.*

* 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.