Simvastatin Tablet, Film Coated
Product Images NDC 71610-609
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Product Visual Gallery
This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 71610-609). 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 0610 45)
Bottle Label 80 mg (71610 0611 45)
Aphena Pharma Solutions (TN)
Footnote For Table 3 (Footnote For Table 3)
This text provides information on the results of a chemical assay, and the potential inhibitors that could affect CYP3A4. It also clarifies that "Simvastatin acid" refers to the p-hydroxyacid of simvastatin. However, there is a lack of information on the effect of grapefruit juice on simvastatin pharmacokinetics. The text provides details about the administration of grapefruit juice in double-strength and single-strength doses, along with simvastatin.*
Figure 9 (Simvastatin 10)
Table2 (Simvastatin 2)
Structure (Simvastatin 3)
Table 3 (Simvastatin 4)
Table 4 (Simvastatin 5)
Figure 5 (Simvastatin 6)
Figure 6 (Simvastatin 7)
Figure 7 (Simvastatin 8)
Figure 8 (Simvastatin 9)
Table 1 (Table1)
This is a list of drug interactions associated with increased risk of myopathy/rhabdomyolysis. The list includes prescribing recommendations for interacting agents such as strong CYP3A4 inhibitors, HIV protease inhibitors, and other medications. Simvastatin, a cholesterol-lowering medication, should not be taken with certain medications such as verapamil, diltiazem, and amiodarone, unless under specific prescribing recommendations. Additionally, niacin should not be taken with simvastatin while for patients with HOFH, Lomitapide should not be used. There is an instruction to avoid grapefruit juice as well.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.