Simvastatin
Product Images NDC 24658-504

View Photos of Packaging, Regulatory Labels, and Product Appearance

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

10mg  1000 Counts
This is a description of a medication called "Simvastatin Tablets, USP," containing 1000 tablets. There is accompanying information regarding adult dosage, instructions for dispensing the tablets, and a DEA number for the medication manufacturer. The text also includes multiple reference numbers and codes for the medication, but it is not clear what they refer to specifically.*
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20 mg (1000s count)

20 mg (1000s count)
Simvastatin is a medication that comes in the form of USP tablets that have 20mg of the active ingredient. The recommended adult dosage is not available in the output, and it is advised to refer to the accompanying document for complete dosage information. The medication should be stored at a temperature between 20-25°C (68-77°F) and dispensed in a container as defined in the USP. The manufacturer is PuraCap Laboratories, located in Laurelton, NY, USA, and the medication is packaged in 1000 tablets.*
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40 mg (1000s count)

40 mg (1000s count)
Simvastatin is a drug used by adults to treat high cholesterol levels. The package contains 1000 tablets and should be kept between 20-25°C. It should be stored out of the reach of children. There is a company insert that provides detailed dosage instructions. The tablets are distributed by PuriCap Laboratories and manufactured by PuraCap Caribe.*
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5mg 1000counts

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80 mg (1000s count)

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Footnote For Table 3 (Footnote For Table 3)

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Figure 9 (Simvastatin 10)

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Table2 (Simvastatin 2)

Table2 (Simvastatin 2)
Adverse reactions reported by patients treated with Simvastatin compared to placebo in a clinical trial. The reactions reported include edema/swelling, abdominal pain, atrial fibrillation, constipation, diabetes mellitus, myalgia, headache, insomnia, bronchitis, sinusitis, eczema, and urinary tract infection.*
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Structure (Simvastatin 3)

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Table 3 (Simvastatin 4)

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Table 4 (Simvastatin 5)

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Figure 5 (Simvastatin 6)

Figure 5 (Simvastatin 6)
This appears to be a table displaying data on major vascular and coronary events related to the use of Simvastatin and Placebo in patients with and without various forms of cardiovascular disease. The table also shows the number of patients studied and the risk ratios for each group.*
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Figure 6 (Simvastatin 7)

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Figure 7 (Simvastatin 8)

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Figure 8 (Simvastatin 9)

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Table 1 (Table1)

Table 1 (Table1)
This text appears to be a table listing drugs that interact with statins to increase the risk of muscle injury called myopathy / rhabdomyolysis. The table lists various medications that should not be prescribed in combination with statins including strong CYP3A4 inhibitors, HIV protease inhibitors, verapamil, diltiazem, amiodarone, and lomitapide. It also mentions some recommendations for prescribing some of these agents with simvastatin, such as avoiding niacin, limiting simvastatin dose while on amiodarone or verapamil, or temporarily suspending simvastatin when taking daptomycin. It also advises avoiding grapefruit juice and danazol with statins. There are a few unclear lines that might be due to errors.*

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