Simvastatin Tablet, Film Coated
Product Images NDC 51655-113

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 51655-113). 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 113 26 Rev A 02 23)

Label for Simvastatin Tablets USP 40 mg, film-coated oral tablets. The package contains 90 tablets and is labeled Rx Only. Label shows storage instructions to keep at 20°-25°C and warns to keep out of reach of children. The label also includes repackaging information by Northwind Pharmaceuticals and various product and batch identification numbers.*

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Footnote For Table 3 (Footnote For Table 3)

Text panel from Simvastatin prescription drug labeling providing detailed notes on chemical assay results, CYP3A4 inhibitors, simvastatin acid definition, and the studied effects of grapefruit juice on simvastatin pharmacokinetics, including administration details for single and double-strength grapefruit juice doses.*

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Figure 9 (Simvastatin 10)

A data table showing lipid-lowering effects of Simvastatin in adolescent patients with heterozygous familial hypercholesterolemia. It compares mean percent changes from baseline for placebo and Simvastatin over 24 weeks, including Total-C, LDL-C, HDL-C, and Apo B values with sample sizes and confidence intervals.*

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Table2 (Simvastatin 2)

Data table listing adverse reactions reported at or above 2% frequency in patients treated with Simvastatin (40 mg) compared to placebo, categorized by body system. It includes side effects such as edema, abdominal pain, atrial fibrillation, constipation, gastritis, diabetes mellitus, myalgia, headache, insomnia, vertigo, bronchitis, sinusitis, eczema, and urinary tract infections, with percentages for each group.*

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Structure (Simvastatin 3)

Chemical structure of Simvastatin, depicting its specific molecular arrangement including rings, hydroxyl groups, and methyl side chains, consistent with the active ingredient Simvastatin.*

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Table 3 (Simvastatin 4)

A data table displaying drug interaction and adjustment information for simvastatin 40 mg film-coated tablets. The table lists drugs and grapefruit juice coadministered with simvastatin, dosing regimens, geometric mean ratio effects on simvastatin pharmacokinetics, and recommendations to avoid certain dosages or adjustments based on clinical and post-marketing experience.*

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Table 4 (Simvastatin 5)

A data table titled Summary of NI Prevent Study Results displaying comparative outcomes between Simvastatin (n=10,269) and Placebo (n=10,267) groups. It summarizes primary, secondary, and tertiary endpoints including mortality, CHD mortality, non-fatal MI, stroke, coronary revascularization, and other procedures with corresponding risk reduction percentages and p-values.*

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Figure 5 (Simvastatin 6)

A forest plot chart illustrating the incidence percentages of major vascular and coronary events comparing Simvastatin and placebo across various patient subgroups. The chart displays risk ratios with 95% confidence intervals, indicating favorability towards Simvastatin or placebo, segmented by factors such as baseline characteristics, diabetes status, vascular disease, cerebrovascular disease, gender, age, and cholesterol levels.*

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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 placebo. The table presents values for total cholesterol (TOTAL-C), LDL cholesterol (LDL-C), and HDL cholesterol (HDL-C) changes across several clinical study arms, with sample sizes (N) listed for each group.*

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Figure 7 (Simvastatin 8)

A data table showing six-week lipid-lowering effects of Simvastatin in Type IV Hyperlipidemia. It presents median percent changes in lipid parameters including Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C for placebo and Simvastatin 40 mg/day and 80 mg/day treatment groups, each with 74 patients.*

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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 percent changes from baseline in various lipid parameters for placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day treatment groups. The table includes columns for Total-C, LDL-C, IDL, VLDL-C, IDL + VLDL-C, LDL-C + IDL, and Non-HDL-C with corresponding values and sample sizes.*

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Table 1 (Table1)

A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing interacting agents and prescribing recommendations for simvastatin. It includes CYP3A4 inhibitors contraindicated with simvastatin, niacin considerations, and dosing limits for drugs like verapamil and amiodarone, plus advice to avoid grapefruit juice.*

* 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.