Pregabalin Capsule
Product Images NDC 71610-993

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-993). 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

Label (71610 0993 30)

Pregabalin 25 mg oral capsules label showing a 30-capsule package. The label includes storage instructions, manufacturer details (ScieGen Pharmaceuticals Inc.), and repackager information (Aphena Pharma Solutions - Tennessee, LLC). The NDC number is 71610-993-30. The label has warnings and batch/expiration placeholders but no visible dates.*

FDA Label Image

Aphena (Aphena)

FDA Label Image

Figure 1 (Pregabalin Fig01)

A line graph showing percent of patients improved versus percent improvement in pain from baseline. It includes four curves comparing Pregabalin dosed at 25 mg, 100 mg, and 200 mg three times a day, alongside a placebo group. The graph illustrates the distribution of patient-reported pain improvement percentages for each treatment group.*

FDA Label Image

Figure 2 (Pregabalin Fig02)

A line graph comparing percent improvement in pain from baseline against the percent of patients improved for Pregabalin 100 mg three times a day versus placebo. The x-axis represents percent improvement in pain, and the y-axis shows the percent of patients improved, illustrating superior outcomes with Pregabalin.*

FDA Label Image

Figure 3 (Pregabalin Fig03)

This is a line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares four groups: Pregabalin 300 mg twice a day, Pregabalin 150 mg twice a day, Pregabalin 75 mg twice a day, and placebo, with improvement percentages on the x-axis and patient improvement percentage on the y-axis.*

FDA Label Image

Figure 4 (Pregabalin Fig04)

Line graph depicting the percentage of patients improved over the percent improvement in pain from baseline for Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo groups. The vertical axis shows the percent of patients improved, and the horizontal axis shows the percent improvement in pain from baseline, ranging from 0 to 100%.*

FDA Label Image

Figure 5 (Pregabalin Fig05)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The y-axis represents percent of patients improved, and the x-axis shows percent improvement in pain from baseline, with vertical lines marking specific improvement thresholds.*

FDA Label Image

Figure 6 (Pregabalin Fig06)

A bar chart comparing responder rates (%) between placebo and various doses of pregabalin in two studies, Study E1 and Study E3. The x-axis lists dose groups including placebo and multiple daily dosages; the y-axis represents responder rates as percentages. The chart indicates statistically significant results versus placebo with asterisks.*

FDA Label Image

Figure 7 (Pregabalin Fig07)

A line chart illustrating seizure reduction as median percent change from baseline plotted against dose in mg/day. The graph includes data points for four studies labeled E1 BD, E2 TID, E3 BD, and E3 TID across doses from 0 (placebo) to 600 mg/day, with p-values indicating statistical significance at various dose levels.*

FDA Label Image

Figure 9 (Pregabalin Fig08)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. Four lines represent Pregabalin daily doses of 800 mg, 450 mg, 300 mg, and a placebo, comparing efficacy in pain improvement across different dosage groups.*

FDA Label Image

Figure 10 (Pregabalin Fig09)

A survival curve chart comparing the estimated percentage of subjects without LTR (likely loss to response or a similar measure) over 180 days between Pregabalin and Placebo. The y-axis shows the estimated percentage from 0% to 100%, and the x-axis shows days from 0 to 180. Pregabalin has a higher percentage of subjects without LTR over time compared to Placebo, shown by a solid line for Pregabalin and a dashed line for Placebo.*

FDA Label Image

Figure 11 (Pregabalin Fig10)

A line graph comparing the percent of subjects improved over time from baseline to Week 12 on the x-axis, with the percent of subjects improved on the y-axis. It shows two lines: one solid line representing Pregabalin and one dotted line representing Placebo, depicting higher improvement percentages for Pregabalin compared to Placebo throughout the measured range.*

FDA Label Image

Figure 12 (Pregabalin Fig11)

A line graph comparing the percent of subjects improved from baseline to Week 16 on the BOCF scale between Pregabalin and placebo groups. The x-axis represents percent improved, ranging from 0 to 100%, and the y-axis shows the percent of subjects improved. Pregabalin demonstrates a higher improvement rate than placebo across the percentage range.*

FDA Label Image

Figure 13 (Pregabalin Fig13)

Bar chart displaying responder rates (%) for three groups: Placebo (22.6%, n=93), 2.5 mg/kg/day Pregabalin (29.1%, n=103), and 10 mg/kg/day Pregabalin (40.6%, n=96). The vertical axis represents responder rate percentage, and the horizontal axis lists the treatment groups with sample sizes.*

FDA Label Image

Cockcroft And Gault Equation (Pregabalin Formula)

A text panel showing the formula for calculating creatinine clearance (CLcr), involving age (years), weight (kg), and serum creatinine (mg/dL), with an adjustment factor of 0.85 for female patients.*

FDA Label Image

Chemical Structure (Pregabalin Str)

Chemical structure of pregabalin, the active ingredient in the product Pregabalin 25 mg capsule by Aphena Pharma Solutions - Tennessee, LLC. The image shows the molecular structure with labeled functional groups including an amino group and a carboxylic acid group.*

* 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.