Simvastatin Tablet, Film Coated
Product Images NDC 71335-1906

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71335-1906). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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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Footnote For Table 3 (Footnote For Table 3)

A text panel containing detailed footnotes and clarifications related to a chemical assay and pharmacokinetic studies of simvastatin. The text references CYP3A4 inhibitors, the chemical form of simvastatin (β-hydroxyacid), and the effects of grapefruit juice on simvastatin metabolism, including dosage and administration specifics for study subjects.*

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Label (Lbl713351906)

Simvastatin 40 mg tablet film-coated label from Bryant Ranch Prepack. The label compares it to Zocor 40 mg tablet and indicates a package size of 30 tablets. Storage and safety instructions are provided, with a barcode and NDC number 71335-1906 visible. The tablet is described as a pink oval.*

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Figure 9 (Simvastatin 10)

A data table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia' displaying mean percent changes in Total-C, LDL-C, HDL-C, and Apo B from baseline over 24 weeks. It compares placebo and Simvastatin groups, showing changes in lipid levels and associated standard deviations.*

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Table2 (Simvastatin 2)

A data table titled 'Adverse Reactions Reported Regardless of Causality by ≥2% of Patients Treated with Simvastatin and Greater than Placebo in 4S.' It compares percentages of various adverse reactions in patient groups treated with Simvastatin (N=2,221) and placebo (N=2,223) across different system disorders, including body as whole, cardiovascular, digestive, endocrine, musculoskeletal, nervous system/psychiatric, respiratory, skin, and urogenital system disorders.*

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Structure (Simvastatin 3)

Chemical structure of the active ingredient Simvastatin depicted as a molecular diagram showing its specific arrangement of atoms and bonds.*

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Table 3 (Simvastatin 4)

A detailed data table outlining the drug interaction, dosage adjustments, and warnings for Simvastatin 40 mg tablets. It includes information on coadministered drugs or grapefruit juice, dosing instructions, geometric mean ratios of drug exposure, and recommendations to avoid certain drug combinations or adjust doses based on clinical experience.*

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Table 4 (Simvastatin 5)

A data table titled 'Summary of Pilot Retention Study Results' comparing Simvastatin (N=10,269) and Placebo (N=10,267) across primary, secondary, and tertiary endpoints such as mortality, non-fatal MI, and coronary revascularization. The table includes counts, percentages, risk reduction percentages with 95% confidence intervals, and p-values for each endpoint.*

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Figure 5 (Simvastatin 6)

A clinical risk ratio chart comparing major vascular and coronary events between Simvastatin and placebo groups. It includes baseline characteristics such as patient counts, presence of coronary heart disease (CHD), diabetes status, gender, age groups, and cholesterol levels, showing incidence percentages and risk ratios with confidence intervals for each subgroup.*

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Figure 6 (Simvastatin 7)

A data table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia'. It presents mean percent change from baseline after 6 to 24 weeks of treatment with different doses of simvastatin and placebo, showing variables such as total cholesterol, LDL cholesterol, and HDL cholesterol percent changes across several clinical studies.*

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Figure 7 (Simvastatin 8)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type IV Hyperlipidemia' showing median percent change from baseline for lipid parameters including Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C. It compares placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day treatments with respective sample sizes (N=74). The table includes median values with 25th and 75th percentile ranges for each group.*

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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 parameters comparing placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day groups, with sample sizes and baseline values noted.*

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Table 1 (Table1)

Table listing drug interactions associated with increased risk of myopathy/rhabdomyolysis for Simvastatin. It categorizes interacting agents, including strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice, with corresponding prescribing recommendations such as dosage limits or 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.