Simvastatin Tablet, Film Coated
Product Images NDC 71610-622

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71610-622). 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 20 mg (71610 0622 15)

Simvastatin USP 20 mg film-coated tablets package label showing 15 tablets. Label includes NDC number 71610-0622-15, storage instructions, manufacturer Puracap Caribe in Dorado, Puerto Rico, and repackager Aphena Pharma Solutions in Cookeville, Tennessee. Label indicates prescription use (RX Only).*

FDA Label Image

Bottle Label 40 mg (71610 0623 15)

Simvastatin USP 40 mg film-coated tablets label showing a package of 15 tablets. The label includes storage instructions to keep between 20-25 degrees Celsius and mentions dispensing in a tight light-resistant container. Manufactured by Puracap Caribe in Dorado, PR and repackaged by Aphena Pharma Solutions in Cookeville, TN. The label indicates prescription use only.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Footnote For Table 3 (Footnote For Table 3)

A partial text panel providing specific scientific notes regarding simvastatin, including information about chemical assay results, CYP3A4 inhibitors that may affect the drug, the chemical form of simvastatin (simvastatin acid), and details on studies involving grapefruit juice and simvastatin pharmacokinetics.*

FDA Label Image

Figure 9 (Simvastatin 10)

A table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia' showing the mean percent change from baseline for various lipid parameters comparing placebo and simvastatin over a 24-week duration.*

FDA Label Image

Table2 (Simvastatin 2)

A table listing adverse reactions reported in patients treated with Simvastatin compared to placebo, with reaction percentages for both groups. Categories include body as a whole, cardiovascular, digestive, endocrine, musculoskeletal, nervous system, respiratory, skin, and urogenital disorders.*

FDA Label Image

Structure (Simvastatin 3)

Chemical structure of simvastatin, illustrating its molecular framework including characteristic rings and functional groups represented with standard chemical notation.*

FDA Label Image

Table 3 (Simvastatin 4)

A data table presenting drug interactions with simvastatin, including coadministered drugs or grapefruit juice, dosing details, and geometric mean ratios for simvastatin with warnings about contraindications and dose adjustments. It includes specific drugs to avoid or adjust dosing with, such as telithromycin, itraconazole, gemfibrozil, amiodarone, and others, with detailed pharmacokinetic interaction data.*

FDA Label Image

Table 4 (Simvastatin 5)

Data table titled 'Summary of Net Protection Study Results' comparing Simvastatin and placebo groups for primary, secondary, and tertiary endpoints, including mortality, CHD mortality, non-fatal MI, stroke, and coronary revascularization, with risk reduction percentages, confidence intervals, and p-values.*

FDA Label Image

Figure 5 (Simvastatin 6)

A forest plot chart comparing major vascular and major coronary events between Simvastatin and placebo groups. The chart includes incidence percentages, risk ratios with 95% confidence intervals, and subgroup analyses by patient characteristics such as CHD status, diabetes, gender, age, LDL-cholesterol, and HDL-cholesterol levels, visually presenting the favorability of Simvastatin versus placebo across these categories.*

FDA Label Image

Figure 6 (Simvastatin 7)

A data table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia Showing Percent Change from Baseline After 6 to 24 Weeks.' The table compares treatments including Simvastatin at various dosages and placebo. Columns present data on total cholesterol, LDL-C, and HDL-C changes in percentages along with sample sizes and study types. Notes at the bottom provide additional context on baseline lipid levels and patient exclusions.*

FDA Label Image

Figure 7 (Simvastatin 8)

A data table presenting median percent change from baseline in lipid-lowering effects of Simvastatin in Type IV Hyperlipidemia over six weeks. It compares treatment groups: placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day, showing changes in Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C levels.*

FDA Label Image

Figure 8 (Simvastatin 9)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type III Hyperlipidemia' presenting median percentage changes from baseline in various lipid parameters including total cholesterol, LDL cholesterol, IDL cholesterol, VLDL cholesterol, non-HDL cholesterol, and HDL cholesterol, comparing placebo and two dosages of Simvastatin (40 mg/day and 80 mg/day). Sample sizes are included for each group.*

FDA Label Image

Table 1 (Table1)

A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing interacting agents with simvastatin and corresponding prescribing recommendations. It includes strong CYP3A4 inhibitors, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice, with specific guidance on dosage limits and contraindications.*

* 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.