Lescol Tablet, Extended Release
Product Images NDC 66758-211

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Lescol (NDC 66758-211). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

Label (Label)

Lescol XL 80 mg extended-release tablets (fluvastatin sodium) in a bottle package of 30 tablets. The label includes dosage form, strength, quantity, and states prescription use only. Manufactured by Sandoz Inc, with NDC 66758-211-31 noted. Storage instructions and child safety warnings are also visible on the label.*

FDA Label Image

Fluvastatin Sodium Structural Formula (Lescol 02)

Chemical structure of fluvastatin sodium, showing its molecular formula C24H25FNO4·Na and a molecular weight of approximately 433.46.*

FDA Label Image

Lescol-03 (Lescol 03)

A Kaplan-Meier survival curve showing the percentage of patients without events over approximately 4.5 years since randomization. The graph compares fluvastatin 80 mg with placebo, with fluvastatin demonstrating a higher percentage of event-free patients throughout the period. Statistical data including Cox P-Value, Log-Rank P-Value, and Hazard Ratio with 95% confidence interval are shown. Patient risk numbers and survival percentages at various time points are displayed below the x-axis.*

FDA Label Image

Lescol-04 (Lescol 04)

A forest plot chart comparing incidence rates of cardiac-related events between Lescol and placebo groups. The events include recurrent cardiac events, cardiac death, nonfatal myocardial infarction (MI), and revascularization. The chart displays risk reduction percentages with confidence intervals and Cox risk ratios with confidence intervals favoring either Lescol or placebo.*

FDA Label Image

Lescol-05 (Lescol 05)

A bar chart depicting change in minimum lumen diameter in millimeters comparing Lescol XL (fluvastatin sodium) and placebo groups under different therapy conditions: Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME). The chart includes sample sizes and p-values indicating statistical significance for each comparison.*

FDA Label Image

Lescol-06 (Lescol 06)

A bar chart comparing percent change in diameter stenosis between Lescol (fluvastatin sodium) and placebo groups in three categories: Monotherapy (Lescol 0.45%, placebo 2.52%), All Patients (Lescol 0.59%, placebo 2.79%), and Combination Therapy with cholestyramine (Lescol 0.96%, placebo 3.65%). Statistically significant differences with p-values 0.043 and 0.014 are shown for Monotherapy and All Patients, respectively, while Combination Therapy shows p=0.138.*

* 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.