Simvastatin Tablet, Film Coated
Product Images NDC 70518-3630

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 70518-3630). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack Inc., 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 simvastatin pharmacokinetics studies. It includes references to chemical assay results, CYP3A4 inhibitors, the β-hydroxyacid form of simvastatin, and specific study details about the effects of grapefruit juice on simvastatin pharmacokinetics under single- and double-strength dosing conditions.*

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Remedy_label (Remedy Label)

Simvastatin 20 mg film-coated oral tablets packaging label showing quantity of 30 tablets. The label displays the drug name prominently with dosage strength, along with manufacturer Biocon Pharma, Iselin, NJ. It includes NDC numbers, storage instructions, repackaging information by RemedyRepack Inc., and a barcode with a QR code on the right.*

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Mm2 (Simvastatin 20mg 70518 3630 01)

Simvastatin 20 mg film-coated tablets label showing quantity of 90 tablets. The label includes the NDC number 70518-3630-01, directions to see the package insert, storage instructions, and repackaging information by RemedyRepack Inc. The manufacturer is Biocon Pharma, Iselin, NJ. The label features the RemedyRepack logo.*

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Figure 9 (Simvastatin 10)

A data table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia (Mean Percent Change from Baseline)'. It compares placebo and simvastatin groups over 24 weeks, showing percent changes from baseline in Total-C, LDL-C, HDL-C, and Apo B lipid levels with sample sizes and confidence intervals.*

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Table2 (Simvastatin 2)

Table summarizing adverse reactions reported at 2% or greater incidence in patients treated with Simvastatin compared to placebo in a clinical study. The table lists reactions by body system, including edema, abdominal pain, atrial fibrillation, gastrointestinal issues, diabetes, muscle pain, nervous system symptoms, respiratory disorders, skin conditions, and urinary infections, with corresponding percentages for Simvastatin and placebo groups.*

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Structure (Simvastatin 3)

Chemical structure diagram of simvastatin, showing its molecular framework with multiple ring systems, hydroxyl, carbonyl, and methyl groups consistent with the active ingredient simvastatin.*

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Table 3 (Simvastatin 4)

A data table presenting dosing adjustments and drug interaction information for simvastatin. The table includes medications and grapefruit juice coadministered with simvastatin, recommended dosing, geometric mean ratios indicating drug interactions, and guidance on avoiding or adjusting doses due to potential interactions or side effects.*

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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 includes columns for number and percentage of patients, risk reduction with confidence intervals, and p-values for mortality, coronary heart disease mortality, non-fatal myocardial infarction, stroke, and coronary revascularization outcomes.*

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Figure 5 (Simvastatin 6)

A forest plot chart titled 'Major Vascular Events' and 'Major Coronary Events' showing incidence percentages and risk ratios with 95% confidence intervals for various patient subgroups comparing Simvastatin versus placebo. Subgroups include baseline characteristics, diabetes status, peripheral vascular disease, cerebrovascular disease, gender, age groups, LDL-cholesterol levels, and HDL-cholesterol levels. The chart visually presents which group favors Simvastatin or placebo based on the position of the confidence intervals.*

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Figure 6 (Simvastatin 7)

A table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia' showing mean percent change from baseline in total cholesterol, LDL-C, and HDL-C after 6 to 24 weeks of treatment. It includes data rows for different doses of Simvastatin and placebo, along with patient counts and time points for measurement.*

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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 changes in lipid measures (Total-C, LDL-C, HDL-C, TG, VLDL-C, Non-HDL-C) from baseline for placebo and simvastatin doses (40 mg/day and 80 mg/day). The table includes sample sizes and median baseline values for patients, summarizing lipid response data.*

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Figure 8 (Simvastatin 9)

A data table labeled 'TABLE 7' showing six-week lipid-lowering effects of simvastatin in type III hyperlipidemia, comparing median percent changes from baseline among groups treated with placebo, simvastatin 40 mg/day, and simvastatin 80 mg/day. The table includes lipid parameters such as Total-C, LDL-C, IDL, VLDL-C, LDL-C to IDL ratio, and non-HDL-C.*

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Table 1 (Table1)

Data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing interacting agents such as CYP3A4 inhibitors, gemfibrozil, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice, along with specific prescribing recommendations for simvastatin dosing adjustments 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.