Fluvastatin Sodium Tablet, Extended Release
Product Images NDC 0781-8017

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Fluvastatin Sodium (NDC 0781-8017). 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

Structural Formula (Image 01)

Chemical structure of fluvastatin sodium, showing the molecular arrangement with a molecular weight of 433.46 and molecular formula C24H25FNO4•Na.*

FDA Label Image

Figure-1 (Image 02)

A line graph titled 'Primary Endpoint - Recurrent Cardiac Events' showing the percentage of patients without events over four and a half years since randomization, comparing Fluvastatin 80 mg and placebo groups. The Y-axis represents the percentage of patients without events, while the X-axis shows years since randomization. The graph includes statistical data such as Cox and Log-Rank P-values and a hazard ratio.*

FDA Label Image

Figure-2 (Image 03)

A data table presenting incidence rates and risk reduction percentages for various cardiac and noncardiac events in patients treated with Fluvastatin Sodium ER compared to placebo. It includes primary and secondary endpoints such as cardiac death, nonfatal myocardial infarction, revascularization, and late revascularization, along with Cox risk ratios and 95% confidence intervals shown graphically to compare Fluvastatin versus placebo outcomes.*

FDA Label Image

Figure-3 (Image 04)

A bar graph titled 'Figure 3: Change in Minimum Lumen Diameter (mm)' showing comparisons between Fluvastatin and placebo across three groups: Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME). The graph displays mean changes in lumen diameter with numerical values and p-values, illustrating differences in effect for each group and treatment.*

FDA Label Image

Figure-4 (Image 05)

A bar chart comparing the change in percentage diameter stenosis among patients treated with Fluvastatin versus placebo. It includes three groups: Monotherapy, All Patients, and Combination Therapy with cholestyramine. Bars show numerical values and p-values indicating statistical comparisons, with Fluvastatin groups showing lower stenosis changes than placebos.*

FDA Label Image

Fluvastatin-xl-100count-label (Image 06)

Label for Fluvastatin Sodium Extended-Release Tablets, USP, 80 mg strength, oral tablet. The label shows the product is Rx only and contains 100 tablets. It is manufactured by Sandoz Inc. The label includes dosage and storage instructions, NDC 0781-8017-01, and safety warnings to keep out of reach of children.*

* 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.