Pregabalin Capsule
Product Images NDC 70518-3643

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 70518-3643). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack Inc., 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

Remedy_label (Remedy Label)

Label for Pregabalin 100 mg oral capsules, containing 90 capsules per package. The label indicates prescription use only (C-V), repackaged by RemedyRepack Inc. It includes storage instructions and manufacturer details from Ascend Labs, LLC, Montvale, NJ. A barcode and a QR code are also present on the label.*

FDA Label Image

Pregabalin-equation (Pregabalin Equation)

A mathematical formula calculating creatinine clearance (CLCr), which adjusts for age, weight, serum creatinine in mg/dL, and includes a multiplication factor of 0.85 for female patients.*

FDA Label Image

Pregabalin-figure-6 (Pregabalin Figure 6)

A bar chart titled 'Study E1' and 'Study E3' showing responder rates (%) for different doses of Pregabalin capsules compared to placebo. The x-axis displays dosing groups with sample sizes, including placebo, 50 mg/day, 150 mg/day, 300 mg/day, and 600 mg/day for Study E1, and placebo, 600 mg/day BID, and 600 mg/day TID for Study E3. The y-axis shows responder rate percentages ranging from 0% to 60%. Several doses in both studies show statistically significant higher responder rates compared to placebo.*

FDA Label Image

Pregabalin-figure-7 (Pregabalin Figure 7)

A line graph depicting seizure reduction as median percentage change from baseline versus daily dose (mg/day) of Pregabalin from multiple studies. The graph shows data points for Studies E1 BID, E2 TID, and E3 BID and TID, with significant p-values highlighted. Doses range from 0 (placebo) to approximately 600 mg/day, demonstrating increased seizure reduction with higher doses.*

FDA Label Image

Study Dpn 1 (Pregabalin Image 1)

A line chart depicting the percent of patients improved versus the percent improvement in pain from baseline for Pregabalin at doses of 25 mg, 100 mg, and 200 mg taken three times a day, compared to placebo. The graph shows these comparative efficacy trends over increasing pain improvement percentages.*

FDA Label Image

Study Sci 1 (Pregabalin Image 10)

A line graph showing the percent of subjects improved over a range of percent improvement from baseline to Week 12 BOCF, comparing Pregabalin and Placebo groups. The y-axis represents the percent of subjects improved, while the x-axis represents the percent improved from baseline to Week 12 BOCF.*

FDA Label Image

Pain Intensity-study Sci 2 (Pregabalin Image 11)

A line graph showing the percent of subjects improved over time from baseline to week 16 measured by BOCF. It compares Pregabalin (solid line) and Placebo (dashed line), with the Pregabalin group generally showing higher percentages of improvement than the placebo group throughout the study period.*

FDA Label Image

Study Dpn 2 (Pregabalin Image 2)

A line graph showing percent improvement in pain from baseline on the x-axis and percent of patients improved on the y-axis. The graph compares results for Pregabalin 100 mg three times a day and placebo, with two lines representing each group across the range of percent improvement.*

FDA Label Image

Study Phn 1 (Pregabalin Image 3)

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 a placebo, illustrating patient improvement trends across these treatments.*

FDA Label Image

Study Phn 2 (Pregabalin Image 4)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. The graph compares three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo, illustrating their relative effectiveness over a range of pain improvement percentages.*

FDA Label Image

Study Phn 3 (Pregabalin Image 5)

A line graph showing the percent of patients improved against 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, with improvement trends illustrated over the pain improvement range from 0% to 100%.*

FDA Label Image

Fibromyalgia Study F1 (Pregabalin Image 8)

A line graph showing percent of patients improved plotted against percent improvement in pain from baseline. It compares four groups: Pregabalin 600 mg daily dose, Pregabalin 450 mg daily dose, Pregabalin 300 mg daily dose, and Placebo. Each group is represented by distinct line styles (solid and dashed).*

FDA Label Image

Fibromyalgia Study F2 (Pregabalin Image 9)

A line chart comparing the estimated percentage of subjects without LTR over 180 days between Pregabalin and placebo groups. The x-axis represents days from 0 to 180, and the y-axis represents the estimated percentage of subjects without LTR from 0% to 100%. Two lines depict the differences in outcomes over time between Pregabalin and placebo.*

FDA Label Image

Pregabalin Structure (Pregabalin Srtuc 1)

Chemical structure of pregabalin showing its molecular configuration, including the amino group, carboxyl group, and side chains. The structure is a standard two-dimensional representation used in pharmaceutical labeling.*

* 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.