Simvastatin Tablet, Film Coated
Product Images NDC 71610-615

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71610-615). 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.

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Bottle Label 10 mg (71610 0615 45)

Simvastatin USP 10 mg film-coated tablets carton label displaying 45 count. The label includes the NDC number 71610-0615-45, storage instructions to keep at 20-25 degrees Celsius and protect from light, manufacturer information Puracap Caribe, and repackager Aphena Pharma Solutions in Cookeville, TN. It states prescription-only use with a barcode and lot, serial, and expiration details.*

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Aphena Pharma Solutions (TN)

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Footnote For Table 3 (Footnote For Table 3)

A text panel providing detailed notes on chemical assay results related to simvastatin, mentioning effects of various CYP3A4 inhibitors and clarifying the role of simvastatin acid. It also discusses the impact of grapefruit juice on simvastatin pharmacokinetics with specifics about dosing regimens in study conditions.*

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Figure 9 (Simvastatin 10)

A table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia' showing mean percent changes from baseline for lipid parameters. It compares placebo and Simvastatin 10 mg over 24 weeks, including total cholesterol, LDL-C, HDL-C, and Apo B values with statistical data presented.*

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Table2 (Simvastatin 2)

Data table presenting adverse reactions reported at a rate of 2% or more in patients treated with Simvastatin 10 mg compared to placebo in the 4S study. The table categorizes reactions by body system and shows percentages for Simvastatin and placebo groups, including reactions such as edema, abdominal pain, atrial fibrillation, constipation, diabetes mellitus, myalgia, headache, insomnia, bronchitis, eczema, and urinary tract infection.*

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Structure (Simvastatin 3)

Chemical structure of simvastatin, showing its specific arrangement of atoms and bonds in a detailed molecular diagram.*

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Table 3 (Simvastatin 4)

A detailed data table showing drug interaction information for simvastatin, including coadministered drugs or grapefruit juice, dosing regimens, geometric mean ratios of AUC and Cmax, and recommendations for dose adjustments or avoidance. The table lists specific drugs, doses, interaction effects, and clinical guidance for simvastatin coadministration.*

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Table 4 (Simvastatin 5)

A data table titled 'Summary of Heart Protection Study Results' comparing Simvastatin and placebo groups across primary, secondary, and tertiary endpoints. It shows patient numbers, percentages, risk reduction with 95% confidence intervals, and p-values for mortality, coronary heart disease mortality, non-fatal myocardial infarction, stroke, and types of revascularization.*

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Figure 5 (Simvastatin 6)

A forest plot chart titled 'Major Vascular Events' and 'Major Coronary Events' comparing incidence percentages and risk ratios for Simvastatin versus placebo across several patient subgroups including those with and without coronary heart disease (CHD), diabetes mellitus, peripheral vascular disease, cerebrovascular disease, gender, age, LDL-cholesterol, and HDL-cholesterol levels. The chart displays risk ratios with 95% confidence intervals, indicating which treatment group is favored.*

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Figure 6 (Simvastatin 7)

A data table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia' showing mean percent change from baseline after 6 to 24 weeks for treatments including Simvastatin at various doses and comparator studies. The table includes columns for treatment, sample size, and percent changes in TOTAL-C, LDL-C, and HDL-C levels.*

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Figure 7 (Simvastatin 8)

A table presenting the six-week lipid-lowering effects of Simvastatin at 40 mg/day and 80 mg/day in patients with type IV hyperlipidemia, compared to placebo. It shows median percent changes from baseline in lipid measures including Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C for each treatment group.*

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Figure 8 (Simvastatin 9)

A data table titled 'Table 7' presenting six-week lipid-lowering effects of Simvastatin in Type III Hyperlipidemia. It reports median percentage changes from baseline in various lipid measures for placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day groups.*

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Table 1 (Table1)

A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing interacting agents such as strong CYP3A4 inhibitors, niacin, verapamil, and others, along with prescribing recommendations related to simvastatin dosage adjustments or contraindications, including avoiding grapefruit juice and specific dose limits for certain drugs.*

* 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.