Pregabalin Capsule
Product Images NDC 70518-3647

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 70518-3647). 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

Mm2 (Pregabalin 150mg 70518 3647 01)

Label for Pregabalin 150 mg oral capsules, containing 60 capsules per bottle. The product is classified as C-V and repackaged by RemedyRepack Inc. The label includes the NDC 70518-3647-01 and manufacturing information from Ascend Labs, LLC, Montvale, NJ. Storage instructions are noted, with directions referencing the package insert.*

FDA Label Image

Remedy_label (Remedy Label)

Label for Pregabalin 150 mg oral capsules by RemedyRepack Inc. The package contains 90 capsules. The label includes prescription-only status, NDC number 70518-3647-00, and repackager information. Directions refer users to the package insert, and storage instructions specify 20-25°C with permitted excursions. Manufacturer is Ascend Labs, LLC, Montvale, NJ.*

FDA Label Image

Pregabalin-equation (Pregabalin Equation)

A pharmacokinetic equation calculating creatinine clearance (CLCr) based on age in years, weight in kilograms, and serum creatinine in mg/dL, including a multiplication factor of 0.85 for female patients. This formula is used for dosing considerations.*

FDA Label Image

Pregabalin-figure-6 (Pregabalin Figure 6)

A bar graph depicting responder rates (%) in two studies, E1 and E3, for Pregabalin at various dosages versus placebo. Study E1 shows increasing responder rates from placebo (14%) to 600 mg/day (51%) with BID dosing. Study E3 compares placebo (9%) to 600 mg/day given BID and TID with responder rates of 43% and 49%, respectively. Sample sizes are indicated below each bar.*

FDA Label Image

Pregabalin-figure-7 (Pregabalin Figure 7)

A line graph displaying seizure reduction as median percent change from baseline versus dose (mg/day) of Pregabalin. The graph shows data from three studies (E1 BID, E2 TID, E3 BID, and E3 TID) with different dosing schedules, illustrating increased seizure reduction at higher doses. Significant p-values are indicated for various points on the graph, and a placebo dose of 0 is noted.*

FDA Label Image

Study Dpn 1 (Pregabalin Image 1)

A line graph depicting the percent of patients improved versus percent improvement in pain from baseline. The graph compares Pregabalin dosed at 200 mg, 150 mg, and 25 mg three times a day against a placebo group, showing trends of patient improvement across these treatment groups.*

FDA Label Image

Study Sci 1 (Pregabalin Image 10)

A line graph showing the percent of subjects improved on the vertical axis versus percent improved from baseline to Week 12 BOCF on the horizontal axis. It compares two groups labeled Pregabalin and Placebo, with the Pregabalin line generally showing higher percentages of improvement across the range.*

FDA Label Image

Pain Intensity-study Sci 2 (Pregabalin Image 11)

Line chart comparing the percent of subjects improved from baseline to Week 16 using the Brief Pain Inventory (BPI) for Pregabalin versus Placebo. The x-axis shows percent improved, and the y-axis shows the percent of subjects improved. Two lines represent Pregabalin and Placebo responses over a range of improvement percentages.*

FDA Label Image

Study Dpn 2 (Pregabalin Image 2)

A line chart displaying the percentage of patients improved versus percent improvement in pain from baseline. The graph compares Pregabalin 100 mg three times a day to placebo, showing two trend lines for patient improvement across varying degrees of pain relief.*

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 for Pregabalin at doses of 75 mg, 150 mg, and 300 mg taken twice a day compared to a placebo. The x-axis represents percent pain improvement from baseline, and the y-axis represents the percent of patients improved, illustrating a comparative effectiveness trend among the dosage groups and placebo.*

FDA Label Image

Study Phn 2 (Pregabalin Image 4)

A line graph showing the percentage of patients improved versus the percent improvement in pain from baseline, comparing Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The graph illustrates patient response rates to different dosages of Pregabalin compared to placebo 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 plotted 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. The graph illustrates the overall trend of patient improvement across these treatments.*

FDA Label Image

Fibromyalgia Study F1 (Pregabalin Image 8)

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 vertical axis represents the percent of patients improved, and the horizontal axis represents percent improvement in pain. Higher doses of Pregabalin show higher patient improvement rates than placebo across the range.*

FDA Label Image

Fibromyalgia Study F2 (Pregabalin Image 9)

A survival curve graph comparing estimated percentage of subjects without lumbosacral radiculopathy (LTR) over 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 showing higher percentages over time compared to Placebo.*

FDA Label Image

Pregabalin Structure (Pregabalin Srtuc 1)

Chemical structure of Pregabalin, showing the molecular arrangement with specific 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.