Simvastatin Tablet, Film Coated
Product Images NDC 51655-448

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 51655-448). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northwind Health Company, 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

Label (51655 448 26 Master Bottle Label Approval Rev A 10 20)

Label (51655 448 26 Master Bottle Label Approval   Rev A 10 20)
This is a 90-tablet package of Simvastatin, a prescription medication used to lower cholesterol levels. The tablets contain 20 mg of the active ingredient and are repackaged by Northwind Pharmaceuticals. The National Drug Code (NDC) for this package is 51655-448-26, and it has a recommended storage temperature of 20-25°C (68-77°F). The medication should be stored in its original container and kept out of reach of children. No information is available on the dosage or any special instructions.*
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Footnote For Table 3 (Footnote For Table 3)

Footnote For Table 3 (Footnote For Table 3)
This text provides information regarding the results of a chemical assay, specifically in relation to CYP3Ad inhibitors such as ketoconazole and erythromycin. It also explains that simvastatin acid is a derivative of simvastatin. However, there has not been a study done to determine the effects of varying amounts of grapefruit juice on simvastatin pharmacokinetics. The text outlines a double-strength and single-strength dosage of grapefruit juice used in a study with simvastatin dosages administered at various times throughout the study.*
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Figure 9 (Simvastatin 10)

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Table2 (Simvastatin 2)

Table2 (Simvastatin 2)
This is a table showing the percentage of patients who reported adverse reactions while being treated with Simvastatin compared to those who were given a placebo. The table has different categories of disorders such as body as a whole, cardiovascular system disorders, digestive system disorders, endocrine disorders, musculoskeletal disorders, nervous system/psychiatric disorders, respiratory system disorders, skin/skin appendage disorders, and urogenital system disorders. The adverse reactions reported for Simvastatin include edema/swelling, abdominal pain, atrial fibrillation, constipation, gastritis, diabetes mellitus, myalgia, headache, insomnia, vertigo, bronchitis, sinusitis, and infections of the urinary tract. For most of the adverse reactions, a higher percentage of patients treated with Simvastatin reported them compared to those given a placebo.*
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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 with information on major vascular events and major coronary events in relation to the use of Simvastatin and Placebo. The table shows the number of patients with or without cardiovascular diseases and the risk ratio for each group. However, without additional context, the details and implications of these findings cannot be determined.*
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Figure 6 (Simvastatin 7)

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Figure 7 (Simvastatin 8)

Figure 7 (Simvastatin 8)
The text is not available as it seems to be a random combination of characters and numbers.*
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Figure 8 (Simvastatin 9)

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Table 1 (Table1)

Table 1 (Table1)
This is a table showing drug interactions associated with increased risk of myopathy and rhabdomyolysis. The table lists various interacting agents such as strong CYP3A4 inhibitors, HIV protease inhibitors, and drugs like Verapamil and Dronedarone. The prescribing recommendations are also mentioned for each of these drugs. For Chinese patients, Niacin is not recommended with Simvastatin. The table also recommends avoiding grapefruit juice and temporarily suspending Simvastatin for patients on Daptomycin. However, the last line of text is not readable and appears to be gibberish.*

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