Simvastatin
Product Images NDC 24658-504

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 24658-504). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Puracap Laboratories, Llc, 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

10mg 1000 Counts

Simvastatin Tablets, USP 10 mg label from PuraCap Laboratories, LLC. The label shows the product name, strength (10 mg), and package size (1000 tablets). It includes dosage form (film-coated tablets), storage instructions, and distributor/manufacturer information. The label also contains a barcode and NDC number 24658-501-10.*

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20 mg (1000s count)

Simvastatin Tablets USP 20 mg label for a 1000-tablet package by PuraCap Laboratories, LLC. The label includes NDC code 24658-502-10, dosage strength, and storage instructions. Distributed by PuraCap Laboratories, LLC, and manufactured by PuraCap Caribe in Dorado, Puerto Rico.*

FDA Label Image

40 mg (1000s count)

Simvastatin Tablets, USP 40 mg film-coated tablets packaging label. The label indicates a quantity of 1000 tablets, distributed by PuraCap Laboratories, LLC, DBA Blu Pharmaceuticals, and manufactured by PuraCap Caribe. It includes dosage and storage instructions and the NDC number 24658-503-10.*

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5mg 1000counts

Label for Simvastatin Tablets, USP 5 mg, showing product name, strength, dosage form, and quantity of 1000 tablets. Label includes NDC 24658-500-10, manufacturer and labeler information for PuraCap Laboratories, LLC, dispensing instructions, storage conditions, and a barcode.*

FDA Label Image

80 mg (1000s count)

Simvastatin Tablets, USP 80 mg packaging label from PuraCap Laboratories, LLC. The label includes the NDC 24658-504-10 and states the container holds 1000 tablets. It notes the tablet strength as 80 mg of simvastatin and provides storage instructions, dosage warnings, and manufacturer details. The label also features a barcode and instructions to keep medication out of children's reach.*

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Footnote For Table 3 (Footnote For Table 3)

A text panel providing detailed study notes related to simvastatin, including information on chemical assay results, the effect of various CYP3A4 inhibitors, clarification on simvastatin acid, and the impact of grapefruit juice on simvastatin pharmacokinetics in different dosing scenarios.*

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Figure 9 (Simvastatin 10)

A table presenting the lipid-lowering effects of Simvastatin compared to placebo in adolescent patients with heterozygous familial hypercholesterolemia over 24 weeks. The table shows median percent change from baseline for Total-C, LDL-C, HDL-C, and Apo B, with dosage, duration, and sample size included for each group.*

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Table2 (Simvastatin 2)

A data table showing adverse reactions reported in patients treated with Simvastatin compared to placebo in a clinical study. The table lists reaction categories including body as a whole, cardiovascular, digestive, endocrine, musculoskeletal, nervous system, respiratory, skin, and urogenital disorders with corresponding percentages for Simvastatin and placebo groups.*

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Structure (Simvastatin 3)

Chemical structure diagram of the active ingredient simvastatin, showing its molecular configuration with labeled chemical groups and bonds.*

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Table 3 (Simvastatin 4)

A data table presenting drug interaction information for Simvastatin. It details coadministered drugs or grapefruit juice, their dosing, the geometric mean ratio of Simvastatin with these, and recommendations for dose adjustments or avoidance based on clinical experience and post-marketing observations.*

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Table 4 (Simvastatin 5)

A data table titled 'Summary of Heart Protection Study Results' comparing outcomes between Simvastatin and placebo groups in primary, secondary, and tertiary endpoints such as mortality, coronary heart disease mortality, non-fatal myocardial infarction, stroke, and coronary revascularization. The table includes event counts, percentages, risk reduction percentages with 95% confidence intervals, and p-values for statistical significance.*

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Figure 5 (Simvastatin 6)

A data table presenting the incidence percentages of major vascular and major coronary events comparing Simvastatin and placebo groups. The table categorizes patients by baseline characteristics including CHD status, diabetes status, peripheral vascular disease, cerebrovascular disease, gender, age, LDL-cholesterol, and HDL-cholesterol levels. It includes a risk ratio plot with confidence intervals representing the comparative risk favoring 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. It compares treatments including Simvastatin at various dosages (10 mg, 20 mg, 40 mg, 80 mg) and placebo across lipid parameters total cholesterol (TOTAL-C), LDL-C, and HDL-C in different study populations and time points.*

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Figure 7 (Simvastatin 8)

A data table presenting six-week lipid-lowering effects of Simvastatin in patients with Type IV Hyperlipidemia. It compares median percent changes from baseline for various lipid measures, including Total-C, LDL-C, HDL-C, TG, VLDL-C, and Non-HDL-C, across placebo and two Simvastatin dosages (40 mg/day and 80 mg/day).*

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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, VLDL-C > 10L, and Non-HDL-C. The table compares results for placebo and two doses of Simvastatin (40 mg/day and 80 mg/day) with sample sizes for each group noted.*

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Table 1 (Table1)

A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' listing interacting agents like strong CYP3A4 inhibitors, niacin, verapamil, amiodarone, lomitapide, daptomycin, and grapefruit juice, along with prescribing recommendations for simvastatin use.*

* 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.