Simvastatin Tablet, Film Coated
Product Images NDC 50090-6459

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 50090-6459). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by A-s Medication Solutions, 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

Footnote For Table 3 (Footnote For Table 3)

A text panel showing detailed notes about simvastatin pharmacokinetics, including chemical assay results, CYP3A4 inhibitor examples, simvastatin acid definition, and effects of grapefruit juice on simvastatin drug levels with specific dosing conditions.*

FDA Label Image

Label Image (Lbl500906459)

Simvastatin 5 mg tablet label from A-S Medication Solutions. The film-coated oral tablets contain 5 mg of simvastatin each. The label indicates a 30-tablet package with storage instructions to keep between 68 to 77 degrees Fahrenheit. The label includes the NDC number 50090-6459-0 and a QR code.*

FDA Label Image

Figure 9 (Simvastatin 10)

A data table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia' showing mean percent change from baseline for placebo and simvastatin groups over 24 weeks. Variables include dosage duration, number of patients, and lipid parameters such as Total-C, LDL-C, HDL-C, and Apo B with mean baseline and standard deviation values.*

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Table2 (Simvastatin 2)

A data table titled 'TABLE 2: Adverse Reactions Reported Regardless of Causality by ≥2% of Patients Treated with Simvastatin and Greater than Placebo in 4S.' The table compares percentages of various adverse reactions for Simvastatin (N=2,221) and Placebo (N=2,223) across categories including Body as a Whole, Cardiovascular System Disorders, Digestive System Disorders, Endocrine Disorders, Musculoskeletal Disorders, Nervous System/Psychiatric Disorders, Respiratory System Disorders, Skin/Skin Appendage Disorders, and Urogenital System Disorders.*

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Structure (Simvastatin 3)

Chemical structure diagram of simvastatin, depicting its molecular configuration with labeled atomic groups and bonds, consistent with the active ingredient in the product Simvastatin.*

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Table 3 (Simvastatin 4)

A data table summarizing drug interaction information for Simvastatin tablets, including dosing details and geometric mean ratios when coadministered with various drugs or grapefruit juice. The table is organized by contraindicated drugs, drugs to avoid with varying doses of Simvastatin, and those requiring no dose adjustments, listing specific drug names, dosage regimens, and effect metrics such as AUC and Cmax ratios.*

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Table 4 (Simvastatin 5)

A data table titled 'Summary of Pilot Network Study Results' comparing Simvastatin and placebo groups on primary, secondary, and tertiary endpoints including mortality, coronary heart disease mortality, non-fatal myocardial infarction, stroke, and revascularization. It presents number of patients, percentage, risk reduction with 95% confidence intervals, and p-values.*

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Figure 5 (Simvastatin 6)

A forest plot chart illustrating Major Vascular Events and Major Coronary Events comparing incidence percentages between Simvastatin and placebo groups across various patient subgroups, including baseline characteristics, diabetes status, cerebrovascular disease, gender, age, and cholesterol levels. The risk ratio with 95% confidence intervals is shown graphically for each subgroup, indicating favor towards 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,' showing mean percent change from baseline after 6 to 24 weeks for treatments including Simvastatin at various dosages and placebo. The table lists sample sizes and percent changes in total cholesterol, LDL-C, and HDL-C.*

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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 levels (Total-C, LDL-C, HDL-C, TG, VLDL-C, Non-HDL-C) from baseline. It compares placebo with two Simvastatin dosages (40 mg/day and 80 mg/day) across groups of 74 patients each.*

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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 lipid parameters including Total-C, LDL-C, IDL, VLDL-C, and Non-HDL-C. The table compares results for placebo and two dosages of simvastatin (40 mg/day and 80 mg/day), along with sample sizes and baseline values.*

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Table 1 (Table1)

Table listing drug interactions associated with increased risk of myopathy or rhabdomyolysis in patients taking simvastatin. It details interacting agents including strong CYP3A4 inhibitors, niacin, verapamil, diltiazem, amiodarone, and others, along 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.