Bottle Label 20 mg (71610 0622 15)
Simvastatin Tablet, Film Coated
Product Images NDC 71610-623
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Product Visual Gallery
This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71610-623). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Aphena Pharma Solutions - Tennessee, 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.
Product Images & Figures Index
Bottle Label 40 mg (71610 0623 15)
Aphena Pharma Solutions (TN)
Footnote For Table 3 (Footnote For Table 3)
The text describes the results of a chemical assay that may be used to identify inhibitors of CYP3A4 enzymes such as ketoconazole and erythromycin. Simvastatin acid, a metabolite of simvastatin, is defined. The effects of grapefruit juice on the pharmacokinetics of simvastatin have been studied at different concentrations in two studies. Grapefruit juice was administered with simvastatin in varying doses over a period of 3 days.*
Figure 9 (Simvastatin 10)
Table2 (Simvastatin 2)
This is a table listing the adverse reactions reported by patients treated with Simvastatin compared to a placebo. The table includes categories 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. Adverse reactions reported with Simvastatin include Edema/swelling, Atrial fibrillation, Constipation, and Eczema, among others.*
Structure (Simvastatin 3)
Table 3 (Simvastatin 4)
Table 4 (Simvastatin 5)
Figure 5 (Simvastatin 6)
This is a statistical report on major vascular events and major coronary events. The report compares the effects of taking Simvastatin versus a placebo in patients with or without certain cardiovascular conditions. The number of patients in each category is provided, as well as the incidence of events. The report includes risk ratios with confidence intervals.*
Figure 6 (Simvastatin 7)
Figure 7 (Simvastatin 8)
The text contains some random characters and does not provide any useful information. Therefore, the description would be "Not available".*
Figure 8 (Simvastatin 9)
Table 1 (Table1)
This is a medical table listing drug interactions that increase the risk of myopathy or rhabdomyolysis with recommended prescribing suggestions and restrictions for various drugs, including strong CYP3A4 inhibitors, protease inhibitors, cyclosporine, and some cardiovascular medications. The table also includes a warning about combining simvastatin with certain medications and grapefruit juice and notes that niacin should not be taken with simvastatin for Chinese patients. The last line appears to be a scanning error and is not readable.*
* 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.
