Fluvastatin Sodium
Product Images NDC 68151-1334

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Fluvastatin Sodium (NDC 68151-1334). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Carilion Materials Management, 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 Image (68151 1334)

Fluvastatin Sodium 40 mg capsule label from Carilion Materials Management with manufacturer Mylan indicated. The label includes lot number 3052003, expiration date 08/14, product code PDM 1334, and a barcode with number 0000001334. It specifies Rx only.*

FDA Label Image

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

Chemical structure of Fluvastatin Sodium, showing its molecular arrangement with fluorophenyl, indole, and sodium carboxylate groups as part of the statin class compound.*

FDA Label Image

Figure 1: Primary Endpoint (Recurrent Cardiac Events (Cardiac Death, Nonfatal MI or Revascularization Procedure) (ITT Population))

A survival curve chart showing the percentage of patients without events over 4.5 years since randomization, comparing Fluvastatin 80 mg to placebo. The graph includes a statistics box with Cox P-value, Log-Rank P-value, and Hazard Ratio with confidence interval, and a patient risk table at the bottom indicating the number and percentage survival at various time points.*

FDA Label Image

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

A forest plot illustrating the incidence of cardiovascular events comparing Fluvastatin sodium versus placebo. It shows risk reduction percentages and Cox risk ratios with 95% confidence intervals for primary and secondary endpoints, including cardiac death, nonfatal myocardial infarction, and revascularization. The graph visually compares treatment outcomes favoring Fluvastatin or placebo.*

FDA Label Image

Figure 3: Change In Minimum Lumen Diameter (mm) (7f4945a8 B0a0 41ec 984c E2a34812bb8b 04)

A bar chart comparing the change in minimum lumen diameter (mm) across treatment groups: Fluvastatin and placebo in monotherapy, all patients, and combination therapy with cholestyramine (CME). Bars show mean changes with sample sizes and p-values indicated for each group.*

FDA Label Image

Figure 4: Change In % Diameter Stenosis (7f4945a8 B0a0 41ec 984c E2a34812bb8b 05)

A bar chart depicting the change in percentage diameter stenosis comparing Fluvastatin and placebo treatments across three groups: Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME). The chart includes sample sizes and p-values indicating statistical significance for differences between Fluvastatin and placebo in Monotherapy (p=0.043) and All Patients (p=0.014), but not in Combination Therapy (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.