Rosuvastatin Tablet, Film Coated
Product Images NDC 82009-189

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Rosuvastatin (NDC 82009-189). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Quallent Pharmaceuticals Health 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

Fig-1 (Fig 1)

A cumulative incidence curve comparing Rosuvastatin (Rosuva) and placebo over approximately 5 years. The y-axis shows cumulative incidence percentage, and the x-axis shows years. The chart includes a hazard ratio (HR 0.56, 95% CI 0.46-0.69) with P<0.001, indicating statistical significance between the groups. A table below lists the number at risk for each group over time.*

FDA Label Image

Fig-2 (Fig 2)

A data table showing clinical study endpoints comparing Rosuvastatin 20 mg to placebo 20 mg. It lists the number of events, hazard ratios with 95% confidence intervals, and p-values for outcomes including primary end point, cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalized unstable angina, and arterial revascularization. A hazard ratio plot visually represents the data.*

FDA Label Image

Fig-3 (Fig 3)

A box plot chart comparing percent change from baseline in LDL-C levels at various doses (10 mg, 20 mg, 40 mg, and 80 mg) of four different statins: Crestor, Atorvastatin, Simvastatin, and Pravastatin. The vertical axis represents percent change from baseline in LDL-C, ranging from 0 to -75. Each drug has multiple dose groups shown, illustrating variability and median changes in LDL-C reduction.*

FDA Label Image

Rosuva-structure (Rosuva Structure)

Chemical structure diagram of Rosuvastatin calcium, showing the molecular arrangement including carbon rings, hydroxyl groups, fluorine, sulfonyl methyl group, and calcium ions associated with the molecule.*

FDA Label Image

Rosuvastatin Tablets 5 mg 500 Tablets (Rosuvastatin Tab Fig 5)

Label for Rosuvastatin Tablets, USP 5 mg film-coated tablets by Quallent Pharmaceuticals Health LLC. The label indicates a package of 500 tablets with NDC 82009-188-05. It includes dosage instructions, manufacturer and distributor information, a barcode, and space for batch details and a 2D code.*

FDA Label Image

Rosuvastatin Tablets 10 mg 500 Tablets (Rosuvastatin Tab Fig 6)

Label for Rosuvastatin Tablets USP 10 mg by Quallent Pharmaceuticals. The film-coated tablets are prescription only, with a package size of 500 tablets. The label includes dosage strength, manufacturer information (Alkem Laboratories Ltd., India), distributor details, storage instructions, and a barcode. It also features a QR code area for batch details and a 2D code.*

FDA Label Image

Rosuvastatin Tablets 20 mg 500 Tablets (Rosuvastatin Tab Fig 7)

Label for Rosuvastatin Tablets, USP 20 mg, film-coated oral tablets. The package contains 500 tablets. The label includes the NDC 82009-190-05 and identifies Quallent Pharmaceuticals Health LLC as the distributor, with manufacturing by Alkem Laboratories Ltd., India. The label displays usage instructions, storage information, a 2D barcode area, and patient information website.*

FDA Label Image

Rosuvastatin Tablets 40 mg 500 Tablets (Rosuvastatin Tab Fig 8)

Label for Rosuvastatin Tablets, USP 40 mg film-coated tablets in a 500 count container. The label shows 'Rx Only' and the Quallent Pharmaceuticals logo. It includes dosage strength, storage information, warnings, manufacturer (Alkem Laboratories Ltd., India), and distributor details (Quallent Pharmaceuticals Health LLC). A barcode and a section for batch details and 2D code are also visible.*

* 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.