Simvastatin Tablet, Film Coated
Product Images NDC 70518-4102

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 70518-4102). 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.

Product Images & Figures Index

FDA Label Image

Footnote For Table 3 (Footnote For Table 3)

Footnote For Table 3 (Footnote For Table 3)
Text excerpt discussing chemical assay results and interactions related to Simvastatin 5 mg film-coated tablets by REMEDYREPACK INC. It references CYP3A4 inhibitors, grapefruit juice effects on pharmacokinetics, and dosing details in specific study conditions.*
FDA Label Image

Mm1 (Simvastatin 5mg 70518 4102 00 (1))

Mm1 (Simvastatin 5mg 70518 4102 00 (1))
Simvastatin 5 mg film-coated tablet label with a quantity of 30 tablets. The label includes the RemedyRepack logo and indicates the product is for prescription use only. Manufacturer information lists Biocon Pharma, Iselin, NJ. The label also provides storage instructions and repackaging details by RemedyRepack Inc., Indiana, PA.*
FDA Label Image

Figure 9 (Simvastatin 10)

Figure 9 (Simvastatin 10)
A data table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia.' It presents mean percent changes from baseline for various lipid metrics (Total-C, LDL-C, HDL-C, Apo B) comparing placebo and simvastatin groups over a 24-week duration, with sample sizes, confidence intervals, and baseline mean values included.*
FDA Label Image

Table2 (Simvastatin 2)

Table2 (Simvastatin 2)
A data table listing adverse reactions reported with Simvastatin compared to placebo. It shows the percentage of patients experiencing various side effects across body systems, including edema, abdominal pain, cardiovascular disorders, digestive issues, endocrine disorders, musculoskeletal problems, nervous system symptoms, respiratory disorders, skin conditions, and urogenital infections.*
FDA Label Image

Structure (Simvastatin 3)

Structure (Simvastatin 3)
Chemical structure of Simvastatin, showing its molecular arrangement with various functional groups including hydroxyl, ester, and methyl groups.*
FDA Label Image

Table 3 (Simvastatin 4)

Table 3 (Simvastatin 4)
A detailed data table showing drug interaction information with simvastatin, including coadministered drugs and grapefruit juice, dosing comparisons, geometric mean ratios of pharmacokinetic measures (AUC and Cmax), and dosing adjustments. The table encompasses contraindications, avoidance recommendations for high doses, and specified dose adjustment guidelines.*
FDA Label Image

Table 4 (Simvastatin 5)

Table 4 (Simvastatin 5)
Data table titled 'Summary of Net Pretrial Study Results' showing comparison of outcomes between Simvastatin and placebo groups, including mortality, cardiovascular mortality, non-fatal myocardial infarction, stroke, and revascularization events, with risk reduction percentages and p-values.*
FDA Label Image

Figure 5 (Simvastatin 6)

Figure 5 (Simvastatin 6)
A forest plot chart comparing major vascular and major coronary events between Simvastatin and placebo groups across multiple patient subgroups. The chart displays incidence percentages, risk ratios with 95% confidence intervals, and subgroup characteristics like CHD status, diabetes, peripheral vascular disease, cerebrovascular disease, gender, age, and cholesterol levels.*
FDA Label Image

Figure 6 (Simvastatin 7)

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 placebos, across lipid measures Total-C, LDL-C, and HDL-C. The table includes sample sizes and notes on baseline lipid levels and study conditions.*
FDA Label Image

Figure 7 (Simvastatin 8)

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 from baseline for placebo and Simvastatin 40 mg/day and 80 mg/day treatments. Columns include measures for Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C with associated median percent changes.*
FDA Label Image

Figure 8 (Simvastatin 9)

Figure 8 (Simvastatin 9)
A data table presenting six-week lipid-lowering effects of Simvastatin in Type III hyperlipidemia. It compares median percent changes from baseline for various lipid parameters across three groups: Placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day, detailing changes in Total-C, LDL-C, IDL, VLDL-C, LDL-C > IDL, and Non-HDL-C.*
FDA Label Image

Table 1 (Table1)

Table 1 (Table1)
A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing various interacting agents such as strong CYP3A4 inhibitors, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice, along with prescribing recommendations for simvastatin usage including contraindications, dosage limits, and suspension instructions.*

* 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.