Simvastatin Tablet, Film Coated
Product Images NDC 70377-005

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 70377-005). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocon Pharma 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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10mg 90s Count

Simvastatin Tablets, USP 10 mg film-coated tablet label from Biocon Pharma Inc. The label includes the NDC 70377-002-14, states Rx Only, and indicates a quantity of 90 tablets. It also provides storage instructions and manufacturing details for Biocon Pharma Inc. and PuraCap Caribe.*

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20mg 90s Count

Simvastatin Tablets USP 20 mg film-coated oral tablets, packaged in a container of 90 tablets. The label shows the Biocon logo and indicates the product is Rx Only. Manufactured for Biocon Pharma Inc. and PuraCap Caribe, with storage instructions and dosage information included on the label.*

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40mg 90s Count

Simvastatin Tablets, USP 40 mg film-coated oral tablets label from Biocon Pharma Inc. The label shows the product name, strength, quantity of 90 tablets, and storage instructions. It also includes a barcode, NDC 70377-004-14, and manufacturer information for Biocon Pharma Inc. and PuraCap Caribe.*

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5mg 90s Count

Simvastatin Tablets USP 5 mg film-coated tablets label by Biocon Pharma Inc. The label indicates 90 tablets per container. It includes storage instructions to keep the tablets between 20 to 25°C (68 to 77°F) and directs users to the accompanying insert for complete dosage information. The product is Rx Only and manufactured by PuraCap Caribe in Dorado, PR, USA.*

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80mg 90s Count

The label for Simvastatin Tablets USP 80 mg from Biocon Pharma Inc features the product name prominently with the strength indicated in a blue box. It specifies that each film-coated tablet contains 80 mg of simvastatin and includes the NDC number 70377-005-14. The label states the package contains 90 tablets and mentions it is Rx only. Manufacturer details include Biocon Pharma Inc in Iselin, NJ, and PuraCap Caribe in Dorado, PR.*

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Footnote For Table 3

This text panel provides additional notes related to chemical assay results and pharmacokinetics of Simvastatin, mentioning CYP3A4 inhibitors, simvastatin acid, and the effect of grapefruit juice on drug metabolism studied under different dosing conditions.*

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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 over 24 weeks and 67-106 days duration for placebo and Simvastatin treatments. The table compares values for Total-C, LDL-C, HDL-C, and Apo B with accompanying confidence intervals and baseline mean levels.*

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Table2 (Simvastatin 2)

A data table titled 'Adverse Reactions Reported Regardless of Causality by ≥2% of Patients Treated with Simvastatin and Greater than Placebo in 4S.' It compares the percentage incidence of various adverse reactions between Simvastatin (N=2,221) and Placebo (N=2,223) groups across several disorder categories including body as a whole, cardiovascular, digestive, endocrine, musculoskeletal, nervous system, respiratory, skin, and urogenital disorders.*

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Structure (Simvastatin 3)

Chemical structure of simvastatin showing its molecular framework with multiple rings, hydroxyl group, and ester functionalities.*

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Table 3 (Simvastatin 4)

A data table showing the effects of coadministered drugs or grapefruit juice on the dosing and pharmacokinetics of Simvastatin tablets. The table includes drug names, dosing regimens, Simvastatin dosing adjustments, and geometric mean ratios for area under the curve (AUC) and maximum concentration (Cmax) compared to Simvastatin alone. It details contraindications, warnings, and necessary dose adjustments with various drugs such as Telithromycin, Nelfinavir, Gemfibrozil, and others.*

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Table 4 (Simvastatin 5)

A data table titled Summary of Net Pretrial Study Results showing patient event counts and percentages for Simvastatin and placebo groups, along with risk reduction percentages and p-values. The table includes primary endpoints (mortality, CHD mortality), secondary endpoints (non-fatal MI, stroke), and tertiary endpoints (coronary revascularization and peripheral or other non-coronary revascularization).*

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Figure 5 (Simvastatin 6)

Forest plot chart showing the incidence (%) and risk ratios with 95% confidence intervals of major vascular and major coronary events in patients taking Simvastatin versus placebo. Data is stratified by baseline characteristics including presence of coronary heart disease, diabetes mellitus, peripheral vascular disease, cerebrovascular disease, gender, age, LDL-cholesterol, and HDL-cholesterol levels.*

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Figure 6 (Simvastatin 7)

A data table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia' showing percent change from baseline after 6 to 24 weeks. It compares treatments including Simvastatin at various doses (10 mg, 20 mg, 40 mg, 80 mg) versus placebo, reporting changes in Total cholesterol, LDL-C, and HDL-C levels, along with sample sizes and related footnotes.*

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Figure 7 (Simvastatin 8)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type IV Hyperlipidemia' presenting median percent changes from baseline for lipid parameters including Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C. It compares placebo with simvastatin at 40 mg/day and 80 mg/day dosages in 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 various lipid parameters, including total-C, LDL-C, IDL, VLDL-C, and non-HDL-C, across placebo and simvastatin dosages (40 mg/day, 80 mg/day). The table includes sample sizes and baseline values for different lipid fractions.*

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Table 1 (Table1)

A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing interacting agents such as strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, niacin, and others. The table provides prescribing recommendations for simvastatin dose limits or contraindications when used with these agents.*

* 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.