Fluvastatin Sodium Capsule
Product Images NDC 0378-8020

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Fluvastatin Sodium (NDC 0378-8020). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals 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

Fluvastatin Structural Formula (7f4945a8 B0a0 41ec 984c E2a34812bb8b 01)

Chemical structure of fluvastatin, the active ingredient in Fluvastatin Sodium capsules, showing its molecular arrangement including aromatic rings, hydroxyl groups, and a sodium carboxylate.*

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Figure 1: Primary Endpoint (Recurrent Cardiac Events (Cardiac Death, Nonfatal)

A Kaplan-Meier survival curve chart comparing the percentage of patients without events over years since randomization between Fluvastatin 80 mg and placebo groups. The y-axis shows the percentage of patients without events, and the x-axis shows time in years. Statistics including Cox P-Value, Log-Rank P-Value, and hazard ratios with confidence intervals are displayed in the inset.*

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Figure 2: Fluvastatin Capsules Intervention Prevention Study (Primary and Secondary Endpoints Figure 2: Fluvastatin Capsules Intervention Prevention Study)

A forest plot chart showing risk reduction and Cox risk ratios for cardiovascular events comparing Fluvastatin and placebo groups. The chart lists primary and secondary endpoints such as cardiac death, nonfatal myocardial infarction, and revascularization, with corresponding percentages and confidence intervals illustrating relative risk reduction.*

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Figure 3: Change In Minimum Lumen Diameter (mm) (Image 03)

A bar chart showing the change in minimum lumen diameter (mm) comparing Fluvastatin and placebo groups in three categories: Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME). The chart includes sample sizes and p-values for statistical significance under each category.*

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Figure 4: Change In % Diameter Stenosis (Image 04)

A bar chart depicting the percentage change in diameter stenosis among groups of patients receiving Fluvastatin, placebo, or Fluvastatin combined with cholestyramine (CME). It compares monotherapy, all patients, and combination therapy groups, showing statistical significance values (p-values) above the bars.*

FDA Label Image

Fluvastatin Capsules, Usp 20 mg Bottle Label (Image 05)

Fluvastatin Capsules, USP 20 mg oral capsules supplied in a 30-capsule package by Mylan Pharmaceuticals Inc. The label includes storage instructions, dispensing information, and a barcode with the NDC 0378-8020-93. The capsule is depicted as half brown and half yellow with "20 mg" clearly indicated.*

FDA Label Image

Fluvastatin Capsules, Usp 40 mg Bottle Label (Image 06)

Fluvastatin 40 mg capsules, USP label for oral use by Mylan Pharmaceuticals Inc. The label shows the product name and strength, quantity of 30 capsules, and highlights that the capsules contain fluvastatin sodium equivalent to 40 mg of fluvastatin. Storage instructions specify 20° to 25°C (68° to 77°F) in a light-protected, child-resistant container. The label includes instructions to dispense the accompanying patient information leaflet and bears the Mylan logo along with the NDC 0378-8021-93 barcode.*

* 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.