Pregabalin Solution
Product Images NDC 67877-457

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 67877-457). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascend Laboratories, 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

Pregabalin-image (Pregabalin Image)

The image shows a formula for calculating creatinine clearance (CLCr), involving age in years, weight in kilograms, serum creatinine in mg/dL, and a factor of 0.85 for female patients. This formula appears as part of clinical or pharmacokinetic information related to the Pregabalin oral solution.*

FDA Label Image

Pregabalin-structure (Pregabalin Structure)

Chemical structure diagram of Pregabalin showing its molecular components, including amino and carboxyl functional groups. The diagram represents the active ingredient in the product labeled Pregabalin oral solution 20 mg/mL by Ascend Laboratories, LLC.*

FDA Label Image

Pregabalin-bottle (Pregabalin Bottle)

Label for Pregabalin Oral Solution 20 mg/mL by Ascend Laboratories, LLC. The label specifies the oral solution dosage form with 16 fluid ounces (473 mL) in the container. It includes storage instructions, barcode, and manufacturing details from Alkem Laboratories Ltd., Mumbai, India.*

FDA Label Image

Pregabalin Carton

Packaging label for Pregabalin Oral Solution 20 mg/mL by Ascend Laboratories, LLC. The label shows a 16 fl oz (473 mL) bottle with usage instructions, storage conditions at 25°C (77°F) with allowed excursions, and a note to dispense the accompanying Medication Guide. It indicates prescription use only and includes a barcode and manufacturer Alkem Laboratories Ltd., Mumbai, India.*

FDA Label Image

Pregabalin-chart1.jpg (Pregabalin Chart1)

A line graph comparing the percent improvement in pain from baseline against the percent of patients improved for different doses of Pregabalin (200 mg, 100 mg, 25 mg, each taken three times a day) and a placebo group. The graph shows how patient improvement varies with pain reduction percentages for each treatment.*

FDA Label Image

Pregabalin-chart10 (Pregabalin Chart10)

A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to Week 12 between Pregabalin and placebo groups. The x-axis represents the percent improved from baseline, while the y-axis represents the percent of subjects improved. Two curves show that Pregabalin has higher improvement rates compared to placebo across the improvement scale.*

FDA Label Image

Pregabalin-chart11 (Pregabalin Chart11)

A line graph comparing the percent of subjects improved over time from baseline to week 16 using BOCF method for Pregabalin versus Placebo. The x-axis represents percent improvement from baseline to week 16, and the y-axis shows the percent of subjects improved. The graph depicts Pregabalin with a solid line and Placebo with a dotted line, showing higher improvement percentages for Pregabalin across the range.*

FDA Label Image

Pregabalin-chart2 (Pregabalin Chart2)

A line graph comparing the percent of patients improved versus percent improvement in pain from baseline. It shows two lines: one for Pregabalin 100 mg three times a day and one for placebo, with Pregabalin consistently showing a higher percentage of patient improvement across various pain improvement levels.*

FDA Label Image

Pregabalin-chart3 (Pregabalin Chart3)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline for Pregabalin at 75 mg, 150 mg, and 300 mg dosed twice daily, compared with placebo. The graph visually compares the efficacy across these doses and placebo in a clinical context.*

FDA Label Image

Pregabalin-chart4 (Pregabalin Chart4)

A graph depicting the percent of patients improved versus percent improvement in pain from baseline for Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The plot compares effectiveness in pain reduction across these three groups.*

FDA Label Image

Pregabalin-chart5 (Pregabalin Chart5)

This line graph depicts the percent of patients improved against the percent improvement in pain from baseline, comparing Pregabalin 100 mg and 50 mg taken three times a day with placebo. The graph illustrates the relationship between pain improvement percentages and patient response rates for the treatments.*

FDA Label Image

Pregabalin-chart7new (Pregabalin Chart7new)

A line chart depicting seizure reduction as median percentage change from baseline versus dose (mg/day). It compares data from four study arms: Study E1 BID, Study E2 TID, Study E3 BID, and Study E3 TID, with dose levels at roughly 0, 150, 300, and 600 mg/day. The chart illustrates increasing seizure reduction with higher doses, annotated with p-values indicating statistical significance.*

FDA Label Image

Pregabalin-chart9new1 (Pregabalin Chart9new1)

A Kaplan-Meier survival curve chart comparing the estimated percentage of subjects without 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 distinct lines for Pregabalin and Placebo.*

FDA Label Image

Pregabalin-figure-6new (Pregabalin Figure 6new)

A bar chart presenting Responder Rate (%) from two studies, E1 and E3, for different dosages of Pregabalin oral solution compared to placebo. Study E1 shows increasing responder rates with dosages from 50 mg/day to 600 mg/day administered twice daily (BID). Study E3 compares responder rates at 600 mg/day given BID and three times daily (TID) versus placebo. Sample sizes (N) are indicated below each bar. The chart highlights statistical significance versus placebo.*

FDA Label Image

Pregabalin-figure 9 (Pregabalin Figure 9)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares Pregabalin daily doses of 600 mg, 450 mg, and 300 mg to placebo. The y-axis represents percent of patients improved (0-100%), and the x-axis represents percent improvement in pain from baseline (0-100%). Four distinct lines correspond to each treatment group, with the Pregabalin 600 mg dose showing the highest improvement trend.*

* 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.