Simvastatin
Product Images NDC 65727-069

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 65727-069). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocon Limited, 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

10 mg (30s count)

Simvastatin Tablets, USP 10 mg by Biocon Limited. The label displays the product name, strength (10 mg), dosage form (tablets), and quantity (30 tablets) with the Rx Only designation. Additional information includes storage instructions, manufacturer details, and a barcode. The label also notes the usual adult dosage and origin of manufacture.*

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20 mg (30s count)

Simvastatin 20 mg tablets label by Biocon Limited. The label displays the drug name, strength, dosage form, and quantity (30 tablets). It includes NDC number 65727-067-12, a barcode, and storage instructions. Manufacturer details for Biocon Limited in Bangalore, India, and Blu Caribe in Puerto Rico are visible. The label indicates prescription use only.*

FDA Label Image

40 mg (30s count)

Simvastatin 40 mg tablets, USP packaging label from Biocon Limited. The label indicates 30 tablets per container, with each film-coated tablet containing 40 mg of Simvastatin. Additional details include storage instructions, prescription-only status, lot and expiration information, and manufacturing locations in India and the USA.*

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5 mg (30s count)

Simvastatin 5 mg Tablets, USP label from Biocon Limited. The package contains 30 film-coated tablets. Includes NDC 65727-065-12 and storage instructions to keep between 20-25°C and out of children's reach. Manufactured in Bangalore, India and Dorado, PR, USA. Barcode and lot/expiration details are visible.*

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80 mg (30s count)

Simvastatin 80 mg tablets packaging label shows the product name and strength, with 30 tablets in the package. It is labeled for prescription use only. The labeler is Biocon Limited. Instructions and manufacturing details are also visible on the label along with a barcode, lot number, and expiration date.*

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Figure 9 (Simvastatin 10)

A table titled 'Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia (Mean Percent Change from Baseline)' comparing placebo and simvastatin over 24 weeks. It presents data on duration, number of subjects, and percent changes in Total-C, LDL-C, HDL-C, and Apo B levels.*

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Table2 (Simvastatin 2)

Table showing adverse reactions reported with Simvastatin compared to placebo in patients from the 4S study. It lists reaction categories such as Body as a Whole, Cardiovascular, Digestive, Endocrine, Musculoskeletal, Nervous System, Respiratory, Skin, and Urogenital system disorders, with corresponding percentages for Simvastatin (N=2,221) and placebo (N=2,223).*

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Structure (Simvastatin 3)

Chemical structure of Simvastatin depicted as a 2D molecular diagram showing atoms and bonds representing its core chemical framework.*

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Table 3 (Simvastatin 4)

A data table titled 'Effect of Coadministered Drugs or Grapefruit Juice on Simvastatin Systemic Exposure,' listing various coadministered drugs or grapefruit juice with their dosing regimens and the geometric mean ratios of simvastatin and simvastatin acid systemic exposure (AUC and Cmax) compared to no coadministered drug. It categorizes drugs as contraindicated, to avoid with different simvastatin doses, or requiring no dosing adjustments.*

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Table 4 (Simvastatin 5)

A summary table presenting heart protection study results comparing Simvastatin and placebo groups. It details primary, secondary, and tertiary endpoints including mortality, coronary heart disease mortality, non-fatal myocardial infarction, stroke, and types of coronary revascularization, showing event counts, risk reductions with 95% confidence intervals, and p-values for statistical significance.*

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Figure 5 (Simvastatin 6)

A forest plot chart titled 'The Effects of Treatment with Simvastatin on Major Vascular Events and Major Coronary Events in HPS.' It compares the incidence and risk ratios of these events between Simvastatin and placebo groups across various patient subgroups, including those with and without coronary heart disease, diabetes mellitus status, gender, age, and cholesterol levels. The risk ratios with 95% confidence intervals are displayed graphically, showing whether Simvastatin favors reduced event risk compared to 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 percent change from baseline after 6 to 24 weeks. The table compares treatments including Simvastatin doses (10 mg, 20 mg, 40 mg, 80 mg) and placebo, with data on total cholesterol, LDL-C, and HDL-C changes, including sample sizes for each group.*

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Figure 7 (Simvastatin 8)

Table showing six-week lipid-lowering effects of Simvastatin in Type IV Hyperlipidemia, presenting median percent changes in lipid parameters (Total-C, LDL-C, HDL-C, TG, VLDL-C, Non-HDL-C) from baseline for placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day groups, each with 74 patients.*

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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 percentage changes from baseline for various lipid parameters including Total-C, LDL-C, IDL, VLDL-C, and Non-HDL-C across groups treated with placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day. The table includes sample sizes (N) and shows comparative lipid changes.*

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Table 1 (Table 1)

A data table listing drug interactions associated with increased risk of myopathy/rhabdomyolysis for Simvastatin by Biocon Limited. It includes interacting agents such as strong CYP3A4 inhibitors, verapamil, diltiazem, amiodarone, amlodipine, lomitapide, and grapefruit juice, with corresponding prescribing recommendations for each.*

* 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.