Crestor
Product Images NDC 43353-290

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Crestor (NDC 43353-290). 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

Bottle Label 40mg (43353 031)

Label for Rosuvastatin Calcium (Crestor) 40 mg tablets, packaging containing 15 tablets. The label includes storage instructions, manufacturer IPR Pharmaceuticals, Inc. from Canovanas, PR, and repackager Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label indicates prescription use only.*

FDA Label Image

Bottle Label 20mg (43353 289)

Label for Rosuvastatin Calcium (Crestor) 20mg tablets with a count of 15 tablets. The label includes storage instructions, manufacturer information (IPR Pharmaceuticals, Inc., Carolina, PR), and repackaging details by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. It specifies the product is RX only and features multiple barcodes alongside the NDC number 43353-0289-15.*

FDA Label Image

Bottle Label 10mg (43353 290)

Packaging label for Rosuvastatin Calcium (Crestor) tablets, 10 mg strength, containing 15 tablets. The label includes storage instructions, manufacturer information (IPR Pharmaceuticals, Inc., Carolina, PR), and repackager details (Aphena Pharma Solutions - Tennessee, LLC, Codekeville, TN). The label notes the product is prescription only (RX Only) and provides a National Drug Code (NDC) number 43353-0290-15.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Strucural Formula (Cbc3470f 9033 4200 Abbd A3ab605e5a66 01)

Chemical structure diagram depicting the active ingredient of CRESTOR. The diagram shows a complex molecule including a fluorophenyl group, a pyrimidine ring with methyl and sulfonyl groups, hydroxyl groups, a carboxylate group, and calcium ions indicating the calcium salt form.*

FDA Label Image

Figure One (Cbc3470f 9033 4200 Abbd A3ab605e5a66 02)

Box plot chart showing percent change from baseline in LDL-C levels for CRESTOR and other statin drugs (Atorvastatin, Simvastatin, Pravastatin) at various doses in milligrams. The chart compares efficacy across different dosages, with vertical axis representing percent change and horizontal axis showing doses for each drug.*

FDA Label Image

Figure Two (Cbc3470f 9033 4200 Abbd A3ab605e5a66 03)

A Kaplan-Meier cumulative incidence curve comparing two groups over 5 years: Placebo (dotted line) and Rosuva (solid line). The vertical axis shows cumulative incidence percentage, while the horizontal axis shows time in years. The graph includes number at risk data for each group at several time points, along with a hazard ratio (HR 0.56, 95% CI 0.46-0.69) and a P-value (<0.001) indicating statistical significance.*

FDA Label Image

Figure Three (Cbc3470f 9033 4200 Abbd A3ab605e5a66 04)

A data table presenting clinical event outcomes comparing Rosuva 20 mg versus placebo 20 mg, including number of events, event rates per 1000 patient-years, hazard ratios with 95% confidence intervals, and P values. The table covers primary endpoint, cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalized unstable angina, and arterial revascularization, accompanied by a hazard ratio forest plot.*

* 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.