Rosuvastatin Tablet, Film Coated
Product Images NDC 71610-797

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Rosuvastatin (NDC 71610-797). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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 (71610 0797 45)

Label (71610 0797 45)
Rosuvastatin 10 mg film-coated tablets carton label showing 45 tablets. The label includes storage instructions to keep between 20-25 degrees Celsius, avoid light and moisture, and keep away from children. Manufactured by GSMS, Inc. and labeled by Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. The label states "RX Only."*
FDA Label Image

Aphena (Aphena)

FDA Label Image

Figure-01 (Figure 1)

Figure-01 (Figure 1)
A line graph showing cumulative incidence percentage over a period of 5 to 6 years comparing two groups: one labeled 'Placebo' represented by a dotted line, and the other labeled 'Rosuva' represented by a solid line. The graph includes hazard ratio (HR 0.56 with 95% confidence interval 0.46-0.69) and a p-value less than 0.001. Below the x-axis, a table lists the number at risk for RSV and Placebo groups at multiple time points from 0 to 5 years.*
FDA Label Image

Figure-02 (Figure 2)

Figure-02 (Figure 2)
A data table presenting clinical study results comparing Rosuvastatin 20 mg to Placebo 20 mg for various cardiovascular endpoints. It includes the number of events, hazard ratios with 95% confidence intervals, P values, and a hazard ratio plot for endpoints such as primary end point, cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalized unstable angina, and arterial revascularization.*
FDA Label Image

Figure-02 (Figure 3)

Figure-02 (Figure 3)
A box plot chart displaying percent change from baseline in LDL-C levels for four statin drugs: Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin. The x-axis shows each drug with varying dose levels (mg) indicated, and the y-axis represents percent change, ranging from 0 to -75%. The chart compares changes for different doses within each drug group.*
FDA Label Image

Structural Formula (Rosuvastatin Str)

Structural Formula (Rosuvastatin Str)
Chemical structure of rosuvastatin calcium, the active ingredient in Rosuvastatin 10 mg film-coated tablets by Aphena Pharma Solutions - Tennessee, LLC. The structure includes characteristic functional groups and the calcium ion complex.*

* 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.