Pregabalin Capsule
Product Images NDC 55154-8097

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Pregabalin (NDC 55154-8097). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cardinal Health 107, 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

Bag Label (Image 01)

Label for PREGABALIN CAPSULES 50 MG contains 10 capsules per package. It includes storage instructions, dosage advisory to see the product insert, and a warning that the dose package is not child resistant and for institutional use only. The label lists Laurus Labs Limited as the manufacturer and distribution information for Major Pharmaceuticals and Cardinal Health.*

FDA Label Image

Bag Label (Image 02)

Label for Pregabalin Capsules 75 mg, package of 10 capsules. The label includes dosage information, storage instructions, and warnings. It shows the product is prescription only (RX ONLY) and mentions distribution by Cardinal Health 107, LLC. The label also lists manufacturers Laurus Labs Limited and Rising Pharmaceuticals, along with distribution by Major® Pharmaceuticals.*

FDA Label Image

Pregabalinchemistrystructure (Pregabalin Chem Structure)

Chemical structure of pregabalin showing its molecular arrangement with distinct functional groups including a carboxyl group (CO2H) and an amino group (NH2). The diagram illustrates the stereochemistry of the molecule relevant to the active ingredient in PREGABALIN capsules.*

FDA Label Image

Pregabalin-equation (Pregabalin Equation)

A mathematical formula describing creatinine clearance (CLCr) calculation involving age, weight, serum creatinine, and a factor for female patients.*

FDA Label Image

Pregabalinfig1 (Pregabalin Fig 01)

A line graph showing the percent of patients improved plotted against percent improvement in pain from baseline for Pregabalin at 200 mg, 100 mg, and 25 mg three times a day, compared to placebo. The graph displays comparative efficacy trends across different doses and placebo over the range of pain improvement levels.*

FDA Label Image

Pregabalinfig2 (Pregabalin Fig 02)

A line graph showing the percent improvement in pain from baseline on the x-axis and the percent of patients improved on the y-axis. It compares two groups: patients treated with Pregabalin 100 mg three times a day and patients treated with placebo, illustrating patient response to the treatment and placebo over varying thresholds of pain improvement.*

FDA Label Image

Pregabalinfig3 (Pregabalin Fig 03)

A line graph showing 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 illustrates a trend of increased pain improvement with higher doses of Pregabalin.*

FDA Label Image

Pregabalinfig4 (Pregabalin Fig 04)

A line chart comparing percent improvement in pain from baseline against percent of patients improved for three groups: Pregabalin 200 mg three times a day, Pregabalin 100 mg three times a day, and placebo. The chart shows higher percentages of patient improvement with Pregabalin doses compared to placebo.*

FDA Label Image

Pregabalinfig5 (Pregabalin Fig 05)

Line chart showing the percent improvement in pain from baseline on the x-axis and the percent of patients improved on the y-axis. The chart compares three groups: Pregabalin 100 mg three times a day, Pregabalin 50 mg three times a day, and placebo. The data lines indicate the distribution of pain improvement among patients for each treatment.*

FDA Label Image

Pregabalinfig6 (Pregabalin Fig 06)

A bar graph comparing responder rates (%) across different doses of pregabalin and placebo in two studies, Study E1 and Study E3. The x-axis shows placebo and varying pregabalin doses (e.g., 50 mg, 80 mg, 300 mg, 600 mg per day), while the y-axis represents responder rates from 0% to 60%. Bars indicate progressively higher responder rates with increased pregabalin doses compared to placebo, with statistical significance noted for some doses.*

FDA Label Image

Pregabalinfig7 (Pregabalin Fig 07)

A line graph showing seizure reduction (median percentage change from baseline) on the y-axis versus dose in mg/day on the x-axis, with four study groups labeled Study E1 BID, Study E2 TID, Study E3 BID, and Study E3 TID. Data points indicate increasing seizure reduction with increasing dose, with statistically significant p-values (≤ 0.0001 and 0.0007) noted for measured points. The graph also notes that dose=placebo is included and that only significant p-values are shown.*

FDA Label Image

Pregabalinfig8 (Pregabalin Fig 08)

A line graph depicting the percent improvement in pain from baseline among patients, comparing placebo with pregabalin at 300 mg, 450 mg, and 600 mg daily doses. The x-axis represents percent improvement in pain, and the y-axis shows the percent of patients improved, with different line styles for each treatment group.*

FDA Label Image

Pregabalinfig9 (Pregabalin Fig 09)

A line graph comparing the estimated percentage of subjects without LTR (Loss to Response) over a period of 180 days between Pregabalin and placebo groups. The x-axis represents days, while the y-axis shows the estimated percentage of subjects without LTR, with Pregabalin consistently showing higher retention than placebo.*

FDA Label Image

Pregabalinfig10 (Pregabalin Fig 10)

A line graph comparing the percent of subjects improved over time from baseline to week 12 for Pregabalin versus placebo. The x-axis represents the percent improved from baseline to week 12 BOCF, while the y-axis shows the percent of subjects improved. The solid line indicates Pregabalin, and the dotted line indicates placebo, with Pregabalin showing higher improvement percentages throughout.*

FDA Label Image

Pregabalinfig11 (Pregabalin Fig 11)

A line graph comparing the percent of subjects improved over a range of percent improvement from baseline to Week 16 BOCF for Pregabalin versus Placebo. The graph shows Pregabalin's improvement curve consistently above that of Placebo across the measured range.*

* 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.