Fluvastatin Sodium Tablet, Film Coated, Extended Release
Product Images NDC 0527-2580

7 FDA label images from Lannett Company, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Fluvastatin Sodium (NDC 0527-2580). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lannett Company, 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.

Product Images & Figures Index

FDA Label Image

Figure 1. Primary Endpoint – Recurrent Cardiac Events (cardiac Death, Nonfatal Mi Or Revascularization Procedure) (itt Population) (Figure 1)

Figure 1. Primary Endpoint – Recurrent Cardiac Events (cardiac Death, Nonfatal Mi Or Revascularization Procedure) (itt Population) (Figure 1)
A Kaplan-Meier survival curve chart depicting the percentage of patients without events over 4.5 years since randomization, comparing Fluvastatin 80 mg and placebo groups. The chart shows two distinct lines representing event-free patient percentages over time, accompanied by a statistics box with p-values and hazard ratio details.*
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Figure 2. Fluvastatin Capsules Intervention Prevention Study (Primary and Secondary Endpoints)

Figure 2. Fluvastatin Capsules Intervention Prevention Study (Primary and Secondary Endpoints)
A table presenting comparative incidence data between Fluvastatin and placebo groups for primary and secondary cardiac events. It includes event counts and percentages, risk reduction percentages with 95% confidence intervals, and Cox risk ratios graphically represented on a horizontal scale indicating favorability toward Fluvastatin or placebo. Events listed include recurrent cardiac events, cardiac death, nonfatal myocardial infarction, revascularization, late revascularization, and noncardiac death.*
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Figure 3 Change In Minimum Lumen Diameter (mm) (Figure 3)

Figure 3 Change In Minimum Lumen Diameter (mm) (Figure 3)
A bar chart comparing the change in minimum lumen diameter (mm) among different groups receiving Fluvastatin alone, placebo, and Fluvastatin combined with cholestyramine (CME) in monotherapy and combination therapy settings. The chart includes sample sizes and p-values indicating statistical comparisons for each group.*
FDA Label Image

Figure 4 Change In % Diameter Stenosis (Figure 4)

Figure 4 Change In % Diameter Stenosis (Figure 4)
A bar chart comparing the percent change in diameter stenosis among patients treated with Fluvastatin versus placebo. The chart is divided into three groups: Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME). Each group shows numerical data bars for Fluvastatin and placebo, with p-values indicating statistical comparisons between treatments.*
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Commercial Label Design (Fluvastatin Label Sciecure)

Commercial Label Design (Fluvastatin Label Sciecure)
Label for Fluvastatin Sodium Extended-Release Tablets 80 mg, oral film-coated tablets, packaged in a container of 30 tablets. The label states it is a prescription drug distributed by Lannett Company, Inc. in Philadelphia, PA, manufactured by Beijing Sciecure Pharmaceutical Co. Ltd. The label includes storage instructions, dosage note, and a barcode.*
FDA Label Image

Fluvastatin Label

Fluvastatin Label
Fluvastatin Sodium Extended-Release Tablets 80 mg film-coated, extended-release tablets. The package contains 100 tablets and is labeled for prescription use only. Distributed by Lannett Company, Inc., Philadelphia, PA. Manufacturer listed as Beijing Scieclure Pharmaceutical Co. Ltd. The label includes storage instructions and dosage information referencing the package insert.*
FDA Label Image

Fluvastatin Sodium Structural Formula (Fluvastatin Sodium Structure2)

Fluvastatin Sodium Structural Formula (Fluvastatin Sodium Structure2)
Chemical structure of fluvastatin sodium, showing its molecular formula C24H25FNO4Na and molecular weight of 433.46. The diagram includes ring structures, functional groups, and sodium ion notation.*

* 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.