Rosuvastatin
Product Images NDC 17856-0186

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Rosuvastatin (NDC 17856-0186). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Atlantic Biologicals Corp, 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

Image Description (17856 0183 01 Case Label)

Label for Rosuvastatin tablets, USP delivering 5mg per tablet, from ATLANTIC BIOLOGICALS CORP. The label includes storage instructions to protect from moisture and maintain temperature between 20°-25°C with excusions permitted between 15°-30°C. Packaging details indicate 100 tablets per container, with an expiration date of 11/21/24 and a barcode, GTIN, lot, and serial number information.*

FDA Label Image

Image Description (17856 0186 01 Case Label)

Label for Rosuvastatin tablets USP, delivering 10 mg per tablet, labeled by Atlantic Biologicals Corp. The label includes storage instructions to protect from moisture, keep in a tight child-resistant container at 20-25°C, and indicates a quantity of 100 tablets. It also shows a barcode, QR code, expiration date of 11/21/24, and additional packaging and distribution details.*

FDA Label Image

Figure-01 (Figure 1)

A line graph showing the cumulative incidence percentage over a period of 6 years comparing Rosuvastatin (Rosuva) and placebo groups. The graph includes a hazard ratio (HR) of 0.56 with 95% confidence interval (0.46-0.69) and a P-value less than 0.001, indicating statistical comparison. A table below the graph shows the number of participants at risk in each group over time.*

FDA Label Image

Figure-02 (Figure 2)

A data table presenting the number of events in a clinical study comparing Rosuvastatin 20 mg and Placebo 20 mg. It details the rate of events per 1000 patient years, hazard ratios with 95% confidence intervals, and p-values for endpoints including major cardiovascular events, cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalized unstable angina, and arterial revascularization, alongside a hazard ratio plot.*

FDA Label Image

Figure-02 (Figure 3)

A box plot chart showing percent change from baseline in LDL-C levels across different doses (10, 20, 40 mg) for Rosuvastatin and Pravastatin, and doses (10, 20, 40, 80 mg) for Atorvastatin and Simvastatin. The vertical axis measures percent change, ranging approximately from 0 to -75, comparing LDL-C lowering effect among the four statins at specified doses.*

FDA Label Image

Structural Formula (Rosuvastatin Str)

Chemical structure diagram of rosuvastatin calcium, displaying the molecule including fluorophenyl, sulfonyl, and carboxylate groups, along with calcium ion association (Ca2+). The structure shows two rosuvastatin molecules complexed with one calcium ion.*

* 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.