Pregabalin Capsule
Product Images NDC 80425-0397

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 80425-0397). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Of 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

Pregabalin 150mg #30 (Pregabalin 150mg 80425 0397 01)

Pregabalin 150 mg capsule packaging label from Advanced Rx of Tennessee, LLC. The label includes storage instructions, a comparison to Lyrica, NDC numbers, lot and expiration date placeholders, and a bar code. The package contains 30 capsules for oral use and is marked C-V with prescription only restriction.*

FDA Label Image

Pregabalin 150mg #60 (Pregabalin 150mg 80425 0397 02)

Pregabalin 150 mg capsule label from Advanced Rx of Tennessee, LLC. The label includes a comparison note to LYRICA, NDC numbers 80425-0397-02 and 50228-0354-90, and states the capsule is C-V controlled substance for Rx only. The packaging mentions storage at 20-25°C and provides lot and expiration date placeholders.*

FDA Label Image

Pregabalin 150mg #90 (Pregabalin 150mg 80425 0397 03)

Pregabalin 150 mg capsule packaging label from Advanced Rx of Tennessee, LLC. The label includes the proprietary name Pregabalin, the dosage strength 150 mg, and quantity of 90 capsules. It lists the NDC numbers, compares the product to Lyrica, and includes storage instructions at 20-25°C.*

FDA Label Image

Pregabalin 225mg #30 (Pregabalin 225mg 80425 0399 01)

Packaging label for Pregabalin 225 mg capsule by Advanced Rx of Tennessee, LLC. The label includes storage instructions, quantity of 30 capsules, and references comparison to Lyrica. It shows NDC numbers, lot number, and expiration date January 31, 2027, along with a barcode and source information from Sciegen Pharmac.*

FDA Label Image

Pregabalin 225mg #60 (Pregabalin 225mg 80425 0399 02)

Packaging label for Pregabalin 225 mg capsules by Advanced Rx of Tennessee, LLC. The label includes the product name, strength (225 mg), dosage form (capsule), quantity (#60), storage instructions (20°-25°C), and prescription-only status (C-V Rx Only). It also features a barcode, lot number, expiration date (1/31/2027), and mentions the product is to be kept out of reach of children.*

FDA Label Image

Pregabalin 225mg #90 (Pregabalin 225mg 80425 0399 03)

Label for Pregabalin 225 mg capsules by Advanced Rx of Tennessee, LLC. The label includes storage instructions, a comparison note to Lyrica, NDC numbers, lot number, expiration date of 1/31/2027, and a barcode. The product is prescription-only, with a reference to Sciegen Pharmac on the label.*

FDA Label Image

Figure 1 (Pregabalin Fig01)

A line chart displaying the percent of patients improved versus percent improvement in pain from baseline for Pregabalin taken three times a day at doses of 200 mg, 100 mg, and 25 mg, compared to placebo. The x-axis shows percent improvement in pain from baseline, and the y-axis shows percent of patients improved.*

FDA Label Image

Figure 2 (Pregabalin Fig02)

A line graph showing percent of patients improved on the y-axis and percent improvement in pain from baseline on the x-axis. Two curves compare Pregabalin 100 mg three times a day versus placebo, illustrating patient response at various levels of pain improvement.*

FDA Label Image

Figure 3 (Pregabalin Fig03)

A line chart showing percent improvement in pain from baseline on the horizontal axis and percent of patients improved on the vertical axis. The graph compares four groups: Pregabalin 300 mg twice daily, Pregabalin 150 mg twice daily, Pregabalin 75 mg twice daily, and placebo, depicting the rate of patient improvement across increasing pain improvement percentages.*

FDA Label Image

Figure 4 (Pregabalin Fig04)

A line graph showing the percent of patients improved versus 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 graph illustrates how patient improvement varies across increasing pain relief thresholds.*

FDA Label Image

Figure 5 (Pregabalin Fig05)

A line graph showing percent improvement in pain from baseline on the x-axis versus percent of patients improved on the y-axis. It compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and Placebo, with the Pregabalin groups showing higher patient improvement percentages than placebo across the pain improvement range.*

FDA Label Image

Figure 6 (Pregabalin Fig06)

A bar graph comparing responder rates (%) in two studies labeled Study E1 and Study E3 for varying dosages of pregabalin versus placebo. The vertical axis shows responder rates from 0 to 60%, with statistically significant increases versus placebo indicated for several dosage groups. Study E1 includes placebo and BID doses of 50 mg/day, 150 mg/day, 300 mg/day, and 600 mg/day. Study E3 includes placebo and BID 300 mg/day, TID 600 mg/day.*

FDA Label Image

Figure 7 (Pregabalin Fig07)

A line graph depicting seizure reduction as median percent change from baseline across different doses of a drug in mg/day. It displays data from four studies, E1, E2, and E3 at twice daily (BD) or three times daily (TID) dosing, with seizure reduction percentages increasing with dose. Significant p-values are indicated for dose comparisons versus placebo.*

FDA Label Image

Figure 9 (Pregabalin Fig08)

A line graph showing the percent of patients improved versus percent improvement in pain from baseline. It compares four groups: Pregabalin 800 mg daily dose, Pregabalin 450 mg daily dose, Pregabalin 300 mg daily dose, and placebo. The graph illustrates the relationship between pain improvement percentage and patient response across different Pregabalin dosages and placebo.*

FDA Label Image

Figure 10 (Pregabalin Fig09)

A survival curve chart displaying the estimated percentage of subjects without LTR (loss to response) over days, comparing Pregabalin (solid line) versus Placebo (dashed line) up to 180 days. The y-axis represents the estimated percentage, and the x-axis represents time in days.*

FDA Label Image

Figure 11 (Pregabalin Fig10)

A line graph comparing the percent of subjects improved from baseline to week 12 between Pregabalin and placebo groups. The x-axis shows percent improvement from 0 to 100, and the y-axis shows percent of subjects improved from 0 to 100. Solid line represents Pregabalin; dashed line represents placebo, indicating higher improvement percentages for Pregabalin across the range.*

FDA Label Image

Figure 12 (Pregabalin Fig11)

A line graph showing percent of subjects improved comparing Pregabalin and placebo from baseline to week 16 measured in BOCF. The x-axis represents percent improvement from 0 to 100%, and the y-axis shows the percent of subjects improved, ranging from 0 to 100%. The graph includes two lines: a solid line for Pregabalin and a dashed line for placebo, illustrating higher improvement rates with Pregabalin.*

FDA Label Image

Figure 13 (Pregabalin Fig13)

A vertical bar chart showing responder rates (%) at three dosages: Placebo, 2.5 mg/kg/day, and 10 mg/kg/day. The responder rates increase from Placebo (22.6%) to 2.5 mg/kg/day (29.1%), and then to 10 mg/kg/day (40.6%). The sample sizes are indicated below each group: 93 for Placebo, 103 for 2.5 mg/kg/day, and 96 for 10 mg/kg/day.*

FDA Label Image

Cockcroft And Gault Equation (Pregabalin Formula)

A formula showing the calculation of creatinine clearance (CLcr) using age in years, weight in kilograms, and serum creatinine in mg/dL, with a multiplier of 0.85 for female patients. This is a pharmacokinetic equation commonly used to assess kidney function.*

FDA Label Image

Chemical Structure (Pregabalin Str)

Chemical structure diagram of Pregabalin, the active ingredient in the product, showing its molecular framework with labeled functional groups including an amino group and a carboxyl 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.