Rosuvastatin Tablet, Film Coated
Product Images NDC 82009-191

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Rosuvastatin (NDC 82009-191). 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.

Product Images & Figures Index

FDA Label Image

Fig-1 (Fig 1)

Fig-1 (Fig 1)
This description provides data on a study comparing the effects of a treatment (RSV) versus a placebo. The treatment group had 8901 individuals at the start, with the numbers decreasing over time as shown in the "Number at risk" table. The placebo group started with 8801 individuals with a similar decline over time. The text also includes specific statistical measurements such as hazard ratio (HR), confidence interval (CI), and significance levels (P<0001).*
FDA Label Image

Fig-2 (Fig 2)

Fig-2 (Fig 2)
This is a statistical analysis comparing the effects of Roswva20mg and Placebo20mg on various cardiovascular events in a group of 8901 individuals. The results show hazard ratios, confidence intervals, and p-values for primary endpoints such as major cardiovascular events(MCE), cardiovascular death, nonfatal stroke, nonfatal MI, hospitalization for unstable angina, and arterial revascularization. The data also includes event rates per 1000 patient-years and defines cardiovascular death to include fatal MI, fatal stroke, sudden death, and other causes of cardiovascular death.*
FDA Label Image

Fig-3 (Fig 3)

Fig-3 (Fig 3)
This is a list of different statin medications (Crestor, Atorvastatin, Simvastatin, Pravastatin) with corresponding doses in milligrams (mg). The table also mentions the percentage change from the baseline in LDL-C levels for each medication and dose.*
FDA Label Image

Rosuva-structure (Rosuva Structure)

Rosuva-structure (Rosuva Structure)
FDA Label Image

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

Rosuvastatin Tablets 5 mg 500 Tablets (Rosuvastatin Tab Fig 5)
This is a pharmaceutical label for Rosuvastatin tablets, with each film-coated tablet containing rosuvastatin calcium equivalent to 5 mg. The usual dosage information is not provided, and there is a warning to keep the medication out of reach of children. The storage instructions suggest keeping the tablets at a temperature range of 20°C to 25°C and protecting them from moisture. The tablets should be dispensed in tight containers with child-resistant closures and come with patient information. The contact number for U.S inquiries is provided, along with manufacturing and distribution details. The label also includes information on the unvarnished area and instructions for labeling with UV Varnish, as well as details for batch and expiration date tracking.*
FDA Label Image

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

Rosuvastatin Tablets 10 mg 500 Tablets (Rosuvastatin Tab Fig 6)
FDA Label Image

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

Rosuvastatin Tablets 20 mg 500 Tablets (Rosuvastatin Tab Fig 7)
This text provides essential information about Rosuvastatin tablets, including dosage instructions, warnings, storage recommendations, and manufacturer details. It also includes a National Drug Code (NDC) and contact information for Quallent Pharmaceuticals Health LLC. The tablets contain rosuvastatin calcium and are meant for prescription use only. The manufacturer is Alkem Laboratories Ltd. based in Mumbai, India. The text also mentions the need to store the tablets in tight containers, protected from moisture, and to keep them out of the reach of children. Additionally, it references a website for patient information.*
FDA Label Image

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

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

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.