Rosuvastatin Calcium Tablet
Product Images NDC 71610-793

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Rosuvastatin Calcium (NDC 71610-793). 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

71610-0793-15 (71610 0793 15)

Rosuvastatin calcium 40 mg oral tablet label for a bottle containing 15 tablets. The label includes the NDC number 71610-0793-15 and storage instructions to keep between 20-25 degrees Celsius. Manufactured by Puracap Caribe and repackaged by Aphena Pharma Solutions - Tennessee, LLC.*

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Aphena (Aphena)

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Figure1.jpg (Figure1)

A box plot chart comparing percent change from baseline in LDL-C levels across different statin drugs and doses. The x-axis shows four drugs: CRESTOR (rosuvastatin) at doses 10, 20, 40 mg, Atorvastatin at 10, 20, 40, 80 mg, Simvastatin at 10, 20, 40, 80 mg, and Pravastatin at 10, 20, 40 mg. The y-axis shows percent change from baseline in LDL-C, with values ranging from 0 to -75%. The plot visualizes the distribution of LDL-C change at various doses for each drug.*

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Figure2.jpg (Figure2)

A cumulative incidence plot comparing placebo and Rosuvastatin (Rosuva) groups over approximately 5 years. The y-axis represents cumulative incidence percentage, and the x-axis shows time in years. The chart includes a hazard ratio (HR 0.56, 95% CI 0.46-0.69) and a P-value (<0.001). Below the chart is a table showing the number of participants at risk in each group over time.*

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Figure3.jpg (Figure3)

A forest plot chart showing hazard ratios with 95% confidence intervals for various cardiovascular endpoints comparing Rosuvastatin 20 mg versus placebo in a clinical study. Endpoints include primary endpoint (MCE), cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalized unstable angina, and arterial revascularization, with event counts and hazard ratios listed alongside.*

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Structure-formula.jpg (Structure Formula)

Chemical structure of rosuvastatin calcium showing its molecular components, including fluorophenyl and sulfonamide groups, hydroxyl groups, and a calcium ion complex. This structure represents the active ingredient in rosuvastatin calcium tablets.*

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Table1.jpg (Table1)

Table presenting adverse reaction percentages for Rosuvastatin at doses 5 mg, 10 mg, 20 mg, and 40 mg compared to placebo. Reactions include headache, nausea, myalgia, asthenia, and constipation with their respective incidence rates across dose groups and totals.*

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Table10.jpg (Table10)

A data table showing median baseline values and median percent changes from baseline with 95% confidence intervals for various cholesterol and lipid parameters including Total-C, Triglycerides, NonHDL-C, VLDL-C + IDL-C, LDL-C, HDL-C, RLP-C, and Apo-E, comparing effects of Rosuvastatin 10 mg and 20 mg doses.*

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Table12.jpg (Table12)

A data table presenting the effects of different rosuvastatin calcium doses (placebo, 5 mg, 10 mg, and 20 mg) on lipid parameters including LDL-C, HDL-C, Total-C, triglycerides (TG), and ApoB. The table displays percentage changes and sample sizes (N) for each dose group.*

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Table2.jpg (Table2)

A data table comparing adverse reactions in patients treated with Rosuvastatin 40 mg (N=700) versus placebo (N=281). The table lists rates of myalgia, arthralgia, headache, dizziness, increased CPK, abdominal pain, and elevated ALT levels greater than three times the upper limit of normal.*

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Table3.jpg (Table3)

Data table presenting adverse reaction rates comparing Rosuvastatin 20 mg with placebo. It lists specific reactions including myalgia, arthralgia, constipation, diabetes mellitus, and nausea, with their respective incidence percentages for each group.*

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Table4.jpg (Table4)

Data table presenting the effects of various coadministered drugs and dosing regimens on the pharmacokinetics of rosuvastatin. It lists drugs, doses, and shows mean ratios of changes in AUC and Cmax compared to rosuvastatin alone, indicating interactions or no effect.*

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Table5.jpg (Table5)

A data table presenting the pharmacokinetic interaction of Rosuvastatin Calcium 40 mg daily over different durations with various coadministered drugs. It details the Rosuvastatin dosage regimens, coadministered drug names and doses, and the mean ratio changes in AUC and Cmax comparing use with and without the coadministered drugs Warfarin, Digoxin, and Oral Contraceptives containing ethinyl estradiol and norgestrel.*

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Table6.jpg (Table6)

A data table showing lipid profile changes by dose for rosuvastatin compared to placebo. Columns include Dose, N (sample size), and percent changes in Total-C, LDL-C, Non-HDL-C, ApoB, TG, and HDL-C. The table lists results for placebo and rosuvastatin doses of 5 mg, 10 mg, 20 mg, and 40 mg.*

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Table7.jpg (Table7)

A data table comparing treatment daily doses for four drugs: Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin, across four dose levels (10 mg, 20 mg, 40 mg, 80 mg). The table lists numerical values related to each drug and dose combination, with some cells left blank.*

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Table8.jpg (Table8)

A comparative data table showing the least squares mean percentage change and 95% confidence intervals for Rosuvastatin and Atorvastatin at weeks 6, 12, and 18 across different dosages (20 mg, 40 mg, and 80 mg). It includes values for 435 Rosuvastatin subjects and 187 Atorvastatin subjects, with some data not available (NA) at week 18 for Rosuvastatin.*

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Table9.jpg (Table9)

A data table presenting lipid level changes (Triglycerides, non-HDL-C, VLDL-C, Total-C, LDL-C, HDL-C) measured across different doses of Rosuvastatin (5 mg, 10 mg, 20 mg, 40 mg) compared with placebo. The table includes sample sizes for each dose group and reports values as ranges or mean changes.*

* 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.