Rosuvastatin Calcium Tablet
Product Images NDC 71610-793

View Photos of Packaging, Regulatory Labels, and Product Appearance

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)

71610-0793-15 (71610 0793 15)
This text provides information about a medication called Rosuvastatin USP, which comes in 15 tablets and has an NDC number. The batch number mentioned is 7.*
FDA Label Image

Aphena (Aphena)

FDA Label Image

Figure1.jpg (Figure1)

FDA Label Image

Figure2.jpg (Figure2)

Figure2.jpg (Figure2)
This snippet provides information on cumulative incidence expressed in percentage, with HR (hazard ratio) of 0.56 (95% CI 0.46-0.68) and a significant p-value of less than 0.001.*
FDA Label Image

Figure3.jpg (Figure3)

FDA Label Image

Structure-formula.jpg (Structure Formula)

FDA Label Image

Table1.jpg (Table1)

Table1.jpg (Table1)
This table displays the occurrences of different adverse reactions in a study comparing various treatments. The adverse reactions listed include headaches, nausea, vomiting, asthenia, and constipation. Each adverse reaction's incidence is compared across different treatments, including Rasusv:lslalln, las:A;a"s‘lalln, Ras;;flslalln, RDS:;BS!M[, and Placebo.*
FDA Label Image

Table10.jpg (Table10)

FDA Label Image

Table12.jpg (Table12)

FDA Label Image

Table2.jpg (Table2)

Table2.jpg (Table2)
This is a list of adverse reactions observed in a group of individuals (N=281) who took Rosuvastatin 40 mg. Some common adverse effects included myalgia, arthralgia, headache, dizziness, increased CPR, abdominal pain, and elevated liver enzymes.*
FDA Label Image

Table3.jpg (Table3)

Table3.jpg (Table3)
This text provides information on adverse reactions associated with Rosuvastatin 20 mg. It includes the following adverse reactions and their frequency: Myalgia (76%), Arthralgia (38%), Constipation (33%), Diabetes mellitus (28%), and Nausea (74%).*
FDA Label Image

Table4.jpg (Table4)

FDA Label Image

Table5.jpg (Table5)

Table5.jpg (Table5)
This is not text, but rather a table showing different dosages of Rosuvastatin with various coadministered drugs and their effects on mean ratio, change in AUC, and change in Ca levels. The table includes dosages like 40mg QD for 10 days with Warfarin and others such as 25mg single dose with Warfarin. It also mentions 40mg QD for 12 days with 0.5mg single dose, and other combinations with different medications.*
FDA Label Image

Table6.jpg (Table6)

Table6.jpg (Table6)
This text provides data on the effects of different doses of rosuvastatin on various cholesterol markers such as LDL-C (low-density lipoprotein cholesterol), non-HDL-C (non-high-density lipoprotein cholesterol), ApoB (apolipoprotein B), and HOL-C. Each row represents a specific dose of rosuvastatin and the corresponding changes in these cholesterol markers compared to placebo. The data can be useful for evaluating the efficacy of rosuvastatin in lowering cholesterol levels at different doses for clinical or research purposes.*
FDA Label Image

Table7.jpg (Table7)

Table7.jpg (Table7)
This text provides information on the daily dosage of different statin medications, including Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin. The dosages range from 10 mg to 80 mg for each medication, showing the variation in daily doses for these cholesterol-lowering drugs.*
FDA Label Image

Table8.jpg (Table8)

Table8.jpg (Table8)
This text appears to be providing data on two cholesterol-lowering medications, Rosuvastatin and Alorvastatin, along with the corresponding sample sizes (n=435 and n=187), LS means, and confidence intervals (CIs). The data also includes the percentage changes in cholesterol levels at different timepoints (Week 6, Week 12, Week 18) for different dosage strengths of the medications (20mg, 40mg, 80mg). The information provided gives insights into the efficacy of these drugs in reducing cholesterol levels over time.*
FDA Label Image

Table9.jpg (Table9)

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