Pregabalin Capsule
Product Images NDC 71610-947

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 71610-947). 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 0947 30)

Pregabalin 225 mg capsule label showing the NDC number 71610-947-30. The label indicates a package of 30 capsules, instructions for storage between 20-25 degrees Celsius, and warnings to keep out of reach of children. The manufacturer is ScieGen Pharmaceuticals Inc, with repackaging by Aphena Pharma, Cookeville, TN. Additional details include batch number, expiration date, and barcode.*

FDA Label Image

Aphena (Aphena)

FDA Label Image

Chemical Structure (Pregabalin 01)

Chemical structure of the active ingredient Pregabalin, showing its molecular arrangement with an amino group (NH2) and a carboxyl group (CO2H).*

FDA Label Image

Figure 1 (Pregabalin 02)

A line chart depicting percent of patients improved versus percent improvement in pain from baseline. It compares four treatment 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 chart shows trends of patient improvement percentages across a range of pain improvement levels from 0 to 100 percent.*

FDA Label Image

Figure 2 (Pregabalin 03)

A line graph comparing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 100 mg three times a day and placebo groups. The graph shows two curves representing patient improvement over a range of pain improvement percentages from 0 to 100.*

FDA Label Image

Figure 3 (Pregabalin 04)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at doses of 75 mg, 150 mg, and 300 mg taken twice daily compared to placebo. The graph depicts higher improvement rates for increased Pregabalin doses relative to placebo across the improvement spectrum.*

FDA Label Image

Figure 4 (Pregabalin 05)

A line graph showing the percent of patients improved relative to the percent improvement in pain from baseline. It compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The y-axis represents percent of patients improved, and the x-axis represents percent improvement in pain from baseline.*

FDA Label Image

Figure 5 (Pregabalin 06)

A line graph showing the percentage of patients improved plotted against percent improvement in pain. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo, with vertical reference lines at approximately 30 and 50 percent improvement.*

FDA Label Image

Figure 6 (Pregabalin 07)

A bar chart presenting responder rates in two clinical studies labeled Study E1 and Study E3. The vertical axis shows responder rate percentages from 0% to 60%. Study E1 compares placebo to multiple pregabalin dose levels (50 mg/day, 150 mg/day, 300 mg/day, 600 mg/day) administered BID, showing increasing responder rates with higher doses. Study E3 compares placebo to 300 mg/day BID and 600 mg/day TID doses, with higher responder rates at active doses.*

FDA Label Image

Figure 7 (Pregabalin 08)

A line graph depicting seizure reduction as median percentage change from baseline versus dose (mg/day) ranging from 0 to 600. The graph compares results from three studies with different dosing schedules: Study E1 BID, Study E2 TID, and Study E3 BID and TID. Data points show seizure reduction increases with dose, with statistically significant p-values indicated. Placebo is labeled at zero dose.*

FDA Label Image

Figure 9 (Pregabalin 09)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at 300 mg, 450 mg, and 600 mg daily doses compared to placebo. The graph includes multiple curves indicating patient improvement rates across different pain improvement percentages.*

FDA Label Image

Figure 10 (Pregabalin 10)

A Kaplan-Meier survival curve chart showing the estimated percentage of subjects without LTR over a 180-day period. Two lines are plotted: one solid line representing Pregabalin and one dashed line for Placebo, indicating higher survival without LTR in the Pregabalin group compared to Placebo over time.*

FDA Label Image

Figure 11 (Pregabalin 11)

A line graph showing the percentage of subjects improved comparing Pregabalin and placebo groups over percent improvement from baseline to Week 12 BOCF. The vertical axis represents percent of subjects improved (0 to 100%), and the horizontal axis shows percent improvement from baseline (greater than 0 to 100%). Pregabalin group shows consistently higher improvement than placebo across the range.*

FDA Label Image

Figure 12 (Pregabalin 12)

A line chart comparing the percentage of subjects improved from baseline to Week 16 BOCF (Baseline Observation Carried Forward) between Pregabalin and placebo groups. The x-axis shows percent improvement, and the y-axis shows the percent of subjects improved. Two lines represent Pregabalin and placebo outcomes over the improvement spectrum.*

* 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.