Rosuvastatin Calcium Tablet, Film Coated
Product Images NDC 70518-4143

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Rosuvastatin Calcium (NDC 70518-4143). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Remedy_label (Remedy Label)

Label for Rosuvastatin calcium 10 mg film-coated tablets, packaged in a box of 30 tablets. The label includes dosage strength, quantity per box, and indicates it is for prescription use only. The labeler is RemedyRepack Inc., with manufacturing by Glenmark in Mahwah, NJ. Directions advise referring to the package insert.*

FDA Label Image

Mm2 (Rosuvastatin 10mg 70518 4143 01)

Label for Rosuvastatin 10 mg film-coated tablet containing 1 tablet per package. The label includes the NDC number 70518-4143-01 and indicates the product is prescription only (Rx only). Manufacturer details list Glenmark, Mahwah, NJ, with repackaging by RemedyRepack Inc., Indiana, PA. Storage instructions mention keeping the medication at 20-25°C with permitted excursions to 15-30°C.*

FDA Label Image

Mm3 (Rosuvastatin 10mg 70518 4143 02)

Label for Rosuvastatin calcium 10 mg oral film-coated tablets, packaged in a quantity of 90 tablets. The label includes a bar code, QR code, and states the product is RX only. It is repackaged by RemedyRepack Inc., Indiana, PA, with the original manufacturer listed as Glenmark, Mahwah, NJ. Storage instructions specify a temperature range of 20-25°C with permitted excursions. The label advises keeping medication out of children's reach and refers users to the package insert for directions.*

FDA Label Image

Figure1 (Figure1)

A Kaplan-Meier cumulative incidence curve comparing Rosuvastatin calcium (Rosuva) tablets, film coated, 10 mg oral dosage, to placebo over a period of 5 years. The graph shows lower cumulative incidence for Rosuva versus placebo, with hazard ratio (HR) 0.56 (95% CI 0.46-0.69) and P<0.001. Number at risk data for both groups is displayed below the x-axis.*

FDA Label Image

Figure2 (Figure2)

A data table presenting clinical trial event rates comparing Rosuvastatin calcium 20 mg and placebo 20 mg in 8901 patients each. Events include primary endpoint, cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalized unstable angina, and arterial revascularization. Columns show number of events with rates, hazard ratios with 95% confidence intervals, and p-values, supplemented by a hazard ratio plot for visual comparison.*

FDA Label Image

Figure3 (Figure3)

Box plot chart showing percent change from baseline in LDL-C levels for four statin drugs: Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin at various doses (10, 20, 40 mg, with additional 80 mg for Atorvastatin and Simvastatin). The chart compares LDL-C reduction efficacy across these drugs and doses.*

FDA Label Image

Structure (Structure)

Chemical structure of rosuvastatin calcium showing the molecular arrangement including fluorophenyl, sulfonamide, and hydroxyl functional groups, and calcium ion complexation.*

* 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.