Simvastatin Tablet, Film Coated
Product Images NDC 51655-448

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 51655-448). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northwind Health Company, 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

Label (51655 448 26 Master Bottle Label Approval Rev A 10 20)

Simvastatin 20 mg tablets, USP bottle label showing 90 film-coated tablets for oral use. The label includes storage instructions, a barcode, and the labeler information for Northwind Health Company, LLC. The package indicates prescription-only status and references a package insert for dosage.*

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Footnote For Table 3 (Footnote For Table 3)

This text panel from a Simvastatin 20 mg film-coated tablet label contains detailed footnotes and explanations related to chemical assay results, CYP3A4 inhibitors, simvastatin acid, and the effects of grapefruit juice on simvastatin pharmacokinetics from various studies involving different dosing protocols.*

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Figure 9 (Simvastatin 10)

A data table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia.' It compares the mean percent change from baseline in various lipid measurements (Total-C, LDL-C, HDL-C, Apo B) between placebo and Simvastatin groups over durations of 24 weeks and different measurement counts. The table includes mean baseline values and 95% confidence intervals for each measurement.*

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Table2 (Simvastatin 2)

Table showing adverse reactions reported in patients treated with Simvastatin compared to placebo, listing various body system disorders and their incidence percentages in each group. Categories include body as a whole, cardiovascular, digestive, endocrine, musculoskeletal, nervous system, respiratory, skin, and urogenital disorders.*

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Structure (Simvastatin 3)

Chemical structure diagram of the active ingredient Simvastatin, showing its molecular arrangement and stereochemistry.*

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Table 3 (Simvastatin 4)

A data table presenting dosing information and geometric mean ratios of coadministered drugs or grapefruit juice with simvastatin, including doses, duration, and pharmacokinetic interaction ratios (AUC and Cmax) with simvastatin. The table also lists drugs requiring dose adjustments and those not requiring changes, based on clinical and post-marketing experiences.*

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Table 4 (Simvastatin 5)

A data table summarizing the Net Protection Study results for Simvastatin. It displays primary, secondary, and tertiary endpoints, including mortality, coronary heart disease mortality, non-fatal myocardial infarction, stroke, and coronary revascularization, showing the number and percentage of patients in Simvastatin and placebo groups, along with risk reduction percentages and p-values.*

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Figure 5 (Simvastatin 6)

A forest plot chart displaying major vascular and major coronary events. The chart compares incidence percentages between Simvastatin and placebo groups across various patient subgroups categorized by baseline characteristics, diabetes status, vascular disease, cerebrovascular disease, gender, age, LDL-cholesterol, and HDL-cholesterol levels. Risk ratios with 95% confidence intervals are shown, indicating the relative effect of Simvastatin versus placebo.*

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Figure 6 (Simvastatin 7)

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 compared to placebo. The table presents data for total cholesterol (TOTAL-C), LDL cholesterol (LDL-C), and HDL cholesterol (HDL-C) across different study groups and time points.*

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Figure 7 (Simvastatin 8)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type IV Hyperlipidemia' presenting median percent changes in various lipid parameters including Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C, comparing placebo with Simvastatin at 40 mg/day and 80 mg/day doses. The table includes sample sizes (N=74 per group) and percentage changes with ranges for each parameter.*

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Figure 8 (Simvastatin 9)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type III Hyperlipidemia' showing median percentage changes from baseline for various lipid metrics including Total-C, LDL-C, IDL, VLDL-C, VLDL-C > 10L, and Non-HDL-C. The table compares placebo with Simvastatin at 40 mg/day and 80 mg/day doses, including the number of subjects per group.*

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Table 1 (Table1)

Table listing drug interactions associated with increased risk of myopathy/rhabdomyolysis for Simvastatin. It shows interacting agents such as strong CYP3A4 inhibitors, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice, alongside prescribing recommendations like contraindications, dosage limits, and precautions.*

* 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.