Simvastatin Tablet, Film Coated
Product Images NDC 71610-609

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71610-609). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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.

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Bottle Label 40 mg (71610 0609 45)

Simvastatin USP 20 mg film-coated tablets packaging label displaying the NDC 71610-0609-45. It includes the quantity of 45 tablets, storage instructions between 20-25 degrees Celsius, dispensing directions, manufacturer Puracap Caribe in Dorado, PR, and repackager Aphena Pharma Solutions in Cookeville, TN. The label indicates RX only and contains lot, serial, expiration information, and barcode.*

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Bottle Label 40 mg (71610 0610 45)

Simvastatin USP 40 mg film-coated tablets label showing a package containing 45 tablets. The label includes storage instructions to keep the product between 20-25 degrees Celsius and dispensing information. Manufactured by Puracap Caribe in Dorado, PR, and repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label features NDC number 71610-0610-45 and indicates prescription use only.*

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Bottle Label 80 mg (71610 0611 45)

Simvastatin USP 80 mg film-coated tablets label showing packaging for 45 tablets. Includes storage instructions, manufacturer as Puracap Caribe in Dorado, PR, and packager as Aphena Pharma Solutions in Cookeville, TN. Features NDC number 71610-0611-45, lot number, manufacturing and expiration dates, and a QR code.*

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Aphena Pharma Solutions (TN)

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Footnote For Table 3 (Footnote For Table 3)

A text panel discussing various chemical assay results related to simvastatin, including notes on CYP3A4 inhibitors, simvastatin acid, and the effects of grapefruit juice on simvastatin pharmacokinetics, with details about dosage and administration timing in the studies.*

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Figure 9 (Simvastatin 10)

A data table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia' showing mean percent changes from baseline for lipid measures including Total-C, LDL-C, HDL-C, and Apo B after 24 weeks of treatment for placebo and Simvastatin groups.*

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Table2 (Simvastatin 2)

A data table listing adverse reactions reported in patients treated with Simvastatin compared with placebo. The table categorizes reactions by body system and shows percentage incidence for each group, including conditions such as edema, abdominal pain, atrial fibrillation, gastrointestinal disorders, diabetes mellitus, musculoskeletal symptoms, neurological symptoms, respiratory conditions, skin disorders, and urinary tract infections.*

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Structure (Simvastatin 3)

Chemical structure of Simvastatin, showing its molecular configuration with multiple rings, hydroxyl groups, and side chains characteristic of this lipid-lowering agent.*

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Table 3 (Simvastatin 4)

A data table detailing drug interaction information for Simvastatin tablets. It includes dosing instructions, coadministered drugs or grapefruit juice, and effects on Simvastatin pharmacokinetics such as geometric mean ratios for AUC and Cmax. The table lists drugs to avoid or adjust dosing with based on clinical experience.*

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Table 4 (Simvastatin 5)

A data table titled 'Summary of Heart Protection Study Results' presenting outcomes for Simvastatin versus placebo groups. It includes incidence numbers and percentages for primary (mortality, coronary heart disease mortality), secondary (non-fatal myocardial infarction, stroke), and tertiary endpoints (coronary revascularization, peripheral and other non-coronary revascularization), with risk reductions, 95% confidence intervals, and p-values for statistical significance.*

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Figure 5 (Simvastatin 6)

A forest plot chart comparing the incidence percentages and risk ratios of major vascular and major coronary events between Simvastatin and placebo groups. It includes subgroup analyses by patient characteristics such as coronary heart disease status, diabetes mellitus, peripheral vascular and cerebrovascular disease, gender, age, and cholesterol levels. The chart uses risk ratio scales with confidence intervals to show the relative effect favoring Simvastatin or placebo.*

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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 changes from baseline after 6 to 24 weeks for treatments including Simvastatin at various dosages and placebo, with metrics such as Total-C, LDL-C, and HDL-C changes noted. The table reports group sizes and comparative statistics.*

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Figure 7 (Simvastatin 8)

Table 6 presents the six-week lipid-lowering effects of Simvastatin in Type IV hyperlipidemia, showing median percent changes in lipid fractions (Total-C, LDL-C, HDL-C, TG, VLDL-C, Non-HDL-C) from baseline for placebo, 40 mg/day, and 80 mg/day Simvastatin treatments.*

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Figure 8 (Simvastatin 9)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type III Hyperlipidemia.' It presents median change values from baseline for various lipid parameters (Total-C, LDL-C, IDL, VLDL-C > IDL, VLDL-C > LDL, and Non-HDL-C) across three treatment groups: Placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day. Sample sizes for each group are listed, along with median baseline values footnoted at the bottom.*

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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 related to simvastatin. It includes various CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, niacin, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, lomitapide, daptomycin, and grapefruit juice with specific usage cautions and dosage limits for simvastatin. The table includes a footnote about dosing in patients with homozygous familial hypercholesterolemia (HoFH).*

* 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.