Simvastatin Tablet, Film Coated
Product Images NDC 70518-3648

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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.

Product Images & Figures Index

FDA Label Image

Footnote For Table 3 (Footnote For Table 3)

Footnote For Table 3 (Footnote For Table 3)
This text describes a chemical assay and its results related to CYP3Ad inhibitors like clarithromycin or HIV protease inhibitors. It also mentions simvastatin acid and the effect of grapefruit juice on simvastatin pharmacokinetics, though the latter has not been studied. The administration of grapefruit juice at single-strength or double-strength with simvastatin is described over a period of 3 days.*
FDA Label Image

Remedy_label (Remedy Label)

Remedy_label (Remedy Label)
Simvastatin is a prescription-only tablet medication, produced by Biacon Pharma in Iselin, NJ, with 10mg dosage strength. It comes in a package of 90 tablets and should be kept out of the reach of children. Users should see the package insert for directions on usage. The medication should be stored at a normal room temperature between 20-25°C (B-77°F), with excursions permitted to between 15-30°C (59-26°F) [see USP]. The medication was repackaged by RemedyRepack Inc. in Indiana, PA.*
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Mm2 (Simvastatin 10mg 70518 3648 01)

Mm2 (Simvastatin 10mg 70518 3648 01)
Simvastatin is a medication used for reducing cholesterol and triglycerides levels in the blood. The available presentation is a tablet of 10mg, with 30 tablets per quantity. The medication is RX only and should be kept out of reach from children. The medication label contains instructions to be followed from the package insert. The medication should be stored at temperatures between 20-25°C (88-77°F) with possible excursions permitted up to 15-30°C (59-86°F) [See USP]. The medication was repackaged by RemedyRepack Inc. located in Indiana, PA. The LOT number and expiration date are not available in the given text.*
FDA Label Image

Figure 9 (Simvastatin 10)

Figure 9 (Simvastatin 10)
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Table2 (Simvastatin 2)

Table2 (Simvastatin 2)
This is a table that shows adverse reactions reported by patients treated with Simvastatin compared to patients treated with a placebo. The adverse reactions are grouped by body system disorders and include swelling, abdominal pain, atrial fibrillation, constipation, diabetes mellitus, myalgia, headache, insomnia, bronchitis, sinusitis, eczema, and urinary tract infection. The percentages of patients reporting each adverse reaction are also shown.*
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Structure (Simvastatin 3)

Structure (Simvastatin 3)
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Table 3 (Simvastatin 4)

Table 3 (Simvastatin 4)
FDA Label Image

Table 4 (Simvastatin 5)

Table 4 (Simvastatin 5)
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Figure 5 (Simvastatin 6)

Figure 5 (Simvastatin 6)
This appears to be a table containing medical data related to major vascular events and major coronary events. The table compares the characteristics and risk ratios of patients who were given Simvastatin medication versus a placebo medication. The table includes different subgroups of patients based on their pre-existing conditions like peripheral vascular disease or other heart-related ailments. Risk ratios for different subgroups are also mentioned.*
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Figure 6 (Simvastatin 7)

Figure 6 (Simvastatin 7)
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Figure 7 (Simvastatin 8)

Figure 7 (Simvastatin 8)
The text contains some characters that are not readable and do not make sense. It is not available.*
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Figure 8 (Simvastatin 9)

Figure 8 (Simvastatin 9)
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Table 1 (Table1)

Table 1 (Table1)
This is a list of drug interactions associated with an increased risk of myopathy/rhabdomyolysis, with recommendations for prescribing. It includes strong CYP3A4 inhibitors, HIV protease inhibitors, and other medications that can increase the risk of side effects when taken with simvastatin. For Chinese patients, niacin is not recommended with simvastatin. Certain medications such as verapamil and diltiazem should not be taken in doses higher than a certain amount. For patients with homozygous familial hypercholesterolemia, lomitapide should not exceed a certain dose, and daptomycin should be temporarily suspended when taking simvastatin. Additionally, patients should avoid grapefruit juice. There is also some unclear text at the end that says "WL SvREnce of MUSCS 1008, B0 N EXL=d R SaSt3in When Eg lamizp 08".*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.