Simvastatin Tablet, Film Coated
Product Images NDC 71335-1905

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71335-1905). 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)

Text excerpt from simvastatin prescribing information discussing pharmacokinetic study details, including chemical assay results, CYP3A4 inhibitors, simvastatin acid definition, and grapefruit juice effects on simvastatin metabolism.*

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Label (Lbl713351905)

Label for Simvastatin 10 mg film-coated tablets by Bryant Ranch Prepack, NDC 71335-1905. The label compares this product to Zocor 10 mg tablets. Storage instructions recommend room temperature 20°-25°C (68°-77°F). The label includes a barcode and a lot number 1523487.*

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Figure 9 (Simvastatin 10)

A table presenting lipid-lowering effects of Simvastatin versus placebo in adolescent patients with heterozygous familial hypercholesterolemia, showing mean percent changes from baseline in total-C, LDL-C, HDL-C, and Apo B over 24 weeks along with dosage and duration information.*

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Table2 (Simvastatin 2)

A data table listing adverse reactions reported at a frequency of 2% or more in patients treated with Simvastatin compared to placebo. It categorizes reactions by body system such as Body as a Whole, Cardiovascular, Digestive, Endocrine, Musculoskeletal, Nervous, Respiratory, Skin, and Urogenital systems, showing corresponding percentages for Simvastatin and placebo groups.*

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Structure (Simvastatin 3)

Chemical structure of Simvastatin, a lipid-lowering agent. The diagram shows the molecular arrangement including carbon rings, oxygen atoms, and methyl groups typical for this statin compound.*

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Table 3 (Simvastatin 4)

A data table showing coadministration and dosing information for simvastatin with various drugs and grapefruit juice. It includes dosages, duration, and geometric mean ratios comparing coadministered drug or grapefruit juice effects on simvastatin pharmacokinetics. The table also lists recommendations to avoid or adjust simvastatin dosing to minimize interactions based on clinical or post-marketing experience.*

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Table 4 (Simvastatin 5)

A data table titled Summary of Prevention Study Results, comparing Simvastatin and placebo groups across primary, secondary, and tertiary endpoints including mortality, non-fatal myocardial infarction, stroke, and revascularization outcomes, with risk reduction percentages and p-values shown.*

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Figure 5 (Simvastatin 6)

A forest plot chart comparing the incidence and risk ratios of major vascular and major coronary events between Simvastatin and placebo groups. The chart breaks down data by baseline characteristics including presence of coronary heart disease, diabetes status, peripheral vascular disease, cerebrovascular disease, gender, age groups, and cholesterol levels, showing risk ratios with 95% 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' showing mean percent change from baseline after 6 to 24 weeks. It includes treatment groups with Simvastatin at various doses and comparator groups, listing number of subjects and changes in total cholesterol (TOTAL-C), LDL cholesterol (LDL-C), and HDL cholesterol (HDL-C).*

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Figure 7 (Simvastatin 8)

A data table titled 'TABLE 6 Six-week, Lipid-lowering Effects of Simvastatin in Type IV Hyperlipidemia' showing median percent change in lipid parameters (Total-C, LDL-C, HDL-C, TG, VLDL-C, Non-HDL-C) for placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day groups, each with 74 patients.*

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Figure 8 (Simvastatin 9)

A data table labeled 'TABLE 7' presenting median percentage changes from baseline over six weeks for lipid-lowering effects of simvastatin in type III hyperlipidemia. Columns report variables including Total-C, LDL-C, IDL-C, VLDL-C, and non-HDL-C, comparing placebo with simvastatin at 40 mg and 80 mg daily doses.*

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Table 1 (Table1)

A data table listing drug interactions associated with increased risk of myopathy/rhabdomyolysis for Simvastatin. It includes interacting agents such as strong CYP3A4 inhibitors, niacin, verapamil, amiodarone, lomitapide, and grapefruit juice, alongside corresponding prescribing recommendations like 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.