Simvastatin Tablet, Film Coated
Product Images NDC 70518-3648

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 70518-3648). 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.

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Footnote For Table 3 (Footnote For Table 3)

This text panel provides detailed notes related to pharmacokinetic studies of Simvastatin, including information about chemical assays, CYP3A4 inhibitors, the active metabolite simvastatin acid, and the effects of grapefruit juice on drug metabolism and dosing protocols used in studied interactions.*

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Remedy_label (Remedy Label)

Simvastatin 10 mg film-coated tablets packaging label showing quantity of 90 tablets. The label includes the product name, strength, dosage form, quantity, and repackager information RemedyRepack Inc. It displays a barcode, QR code, NDC number 70518-3648, manufacturer Biocon Pharma, and storage instructions.*

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Mm2 (Simvastatin 10mg 70518 3648 01)

Simvastatin 10 mg film-coated tablet label showing a 30-tablet quantity. The label identifies RemedyRepack Inc. as the repackager and Biocon Pharma, Iselin, NJ, as the manufacturer. It includes the NDC 70518-3648-01, storage instructions, and a QR code. The label is marked RX only.*

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Figure 9 (Simvastatin 10)

This data table presents mean percent changes from baseline in lipid-lowering effects of Simvastatin in adolescent patients with heterozygous familial hypercholesterolemia. It compares placebo and Simvastatin groups over durations of 24 weeks, including measurements for total cholesterol, LDL-C, HDL-C, and Apo B with associated sample sizes and confidence intervals.*

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Table2 (Simvastatin 2)

Data table listing adverse reactions reported with Simvastatin tablets (10 mg) compared to placebo. It shows percentages of patients experiencing various adverse reactions by body system, including edema, abdominal pain, atrial fibrillation, constipation, diabetes mellitus, myalgia, headache, bronchitis, eczema, and urinary tract infections, among others, in patient groups of over 2,200 each.*

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Structure (Simvastatin 3)

Chemical structure of Simvastatin, depicted as a molecular diagram showing its carbon, hydrogen, and oxygen atoms arranged in a steroid-like framework with functional groups consistent with its structure.*

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Table 3 (Simvastatin 4)

A data table detailing drug interaction information for Simvastatin 10 mg film-coated tablets by RemedyRepack Inc. It lists various coadministered drugs and grapefruit juice dosages, the dosing of Simvastatin, and geometric mean ratios indicating effects on Simvastatin's pharmacokinetics such as AUC and Cmax values. The table also includes guidance on avoiding grapefruit juice and dosing adjustments for specific medications.*

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Table 4 (Simvastatin 5)

A data table titled 'Summary of Net Protection Study Results' comparing Simvastatin 10 mg with a placebo on various outcomes including mortality, non-fatal myocardial infarction, stroke, and types of revascularization. The table shows patient counts, risk reduction percentages with confidence intervals, and p-values for statistical significance.*

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Figure 5 (Simvastatin 6)

A forest plot chart illustrating risk ratios and 95% confidence intervals for major vascular and coronary events among different patient subgroups comparing Simvastatin to placebo. The chart categorizes data by baseline characteristics such as presence of CHD, diabetes status, gender, age, LDL and HDL cholesterol levels, showing incidence percentages for both groups and favoring either Simvastatin or placebo along a risk ratio axis from 0.4 to 1.2.*

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Figure 6 (Simvastatin 7)

A data table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia' showing changes in Total-C, LDL-C, and HDL-C levels after treatment with Simvastatin at various doses compared to placebo. The table includes sample sizes, percent changes, and comparison between lower and upper dose studies over different weeks.*

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Figure 7 (Simvastatin 8)

A data table titled 'TABLE 6 Six-week, Lipid-lowering Effects of Simvastatin in Type IV Hyperlipidemia' showing median percent changes from baseline in various lipid parameters (Total-C, LDL-C, HDL-C, TG, VLDL-C, Non-HDL-C) for three groups: Placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day, along with sample size (N) for each group.*

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Figure 8 (Simvastatin 9)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type III Hyperlipidemia' presents median percent changes from baseline for various lipid parameters including Total-C, LDL-C, IDL, VLDL-C, VLDL-C > 10L, and Non-HDL-C across three groups: Placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day.*

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Table 1 (Table1)

Table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing various interacting agents such as CYP3A4 inhibitors, gemfibrozil, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice. The table also provides prescribing recommendations related to simvastatin dosing or contraindications for these interactions.*

* 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.