Simvastatin
Product Images NDC 53808-0952

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 53808-0952). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by State Of Florida Doh Central Pharmacy, 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 Image For 40mg (40mg Blu Pharm)

Simvastatin 40 mg tablets packaging label from State of Florida DOH Central Pharmacy. The label indicates a quantity of 30 tablets, with lot number 13S0251F2B and expiration date April 5, 2014. The label includes pharmacy and location details, along with a UPC barcode.*

FDA Label Image

Label Image For 5mg (5mg Blu Caribe)

Label for Simvastatin 5 mg tablets, package quantity of 60. The label includes lot number, expiration date of March 1, 2014, and is marked RX only. Packaged by State of Florida Central Pharmacy, Tallahassee, FL 32304. UPC barcode present with number 324658300900.*

FDA Label Image

Label Image For 10mg (Simvastatin 10mg)

Label for Simvastatin 10 mg tablets, quantity of 60, labeled by State of Florida DOH Central Pharmacy, Tallahassee, FL. The label includes a lot number, expiration date of 03-09-2015, and a barcode with UPC 324658301105.*

FDA Label Image

Figure 1 (Simvastatin 1)

A data table titled 'Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis' for simvastatin. The table lists interacting agents such as strong CYP3A4 inhibitors, verapamil, diltiazem, amiodarone, and grapefruit juice, along with prescribing recommendations like contraindications or dosage limits to reduce risk.*

FDA Label Image

Figure 9 (Simvastatin 10)

Data table presenting the lipid-lowering effects of Simvastatin compared to placebo in adolescent patients with heterozygous familial hypercholesterolemia over 24 weeks. It shows median percent changes from baseline in total cholesterol, LDL-C, HDL-C, Apo A, and Apo B, including sample sizes and baseline mean and standard deviations.*

FDA Label Image

Figure 2 (Simvastatin 2)

A data table listing adverse reactions reported by 2% or more of patients treated with Simvastatin versus placebo in a clinical study. It compares percentages of patients experiencing various disorders such as edema, abdominal pain, cardiovascular disorders, digestive disorders, diabetes mellitus, musculoskeletal disorders, psychiatric disorders, respiratory disorders, skin conditions, and urinary tract infections in two groups: Simvastatin (N=2,221) and placebo (N=2,223).*

FDA Label Image

Structure (Simvastatin 3)

Chemical structure of simvastatin shown as a 2D molecular diagram depicting its distinct functional groups and stereochemistry.*

FDA Label Image

Figure 3 (Simvastatin 4)

Data table showing the effect of coadministered drugs or grapefruit juice on Simvastatin systemic exposure. It details dosing of coadministered drugs or grapefruit juice, Simvastatin doses, and geometric mean ratios (with/without coadministered drugs) for simvastatin acid and simvastatin. The table includes contraindications, recommendations to avoid grapefruit juice or certain drug combinations with Simvastatin, and notes on dosing adjustments.*

FDA Label Image

Table 4 (Simvastatin 5)

A data table titled 'Summary of Pilot Retention Study Results' comparing outcomes for Simvastatin and Placebo groups. It shows primary, secondary, and tertiary endpoints including mortality, CHD mortality, non-fatal MI, stroke, and revascularization procedures, with counts, percentages, risk reductions, confidence intervals, and p-values.*

FDA Label Image

Figure 5 (Simvastatin 6)

A figure depicting major vascular and coronary events in patients treated with Simvastatin versus placebo. The chart presents risk ratios with 95% confidence intervals across various patient subgroups, including baseline characteristics, diabetes status, peripheral vascular disease, gender, age, LDL-cholesterol, and HDL-cholesterol levels, showing comparison of incidence rates and risk favors between Simvastatin and placebo groups.*

FDA Label Image

Figure 6 (Simvastatin 7)

A data table titled 'Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia' showing median percent change from baseline in total cholesterol, LDL-C, and HDL-C after 6 to 24 weeks of treatment with various doses of Simvastatin compared to placebo in multiple clinical studies.*

FDA Label Image

Figure 7 (Simvastatin 8)

A data table titled 'Six-week, Lipid-lowering Effects of Simvastatin in Type IV Hyperlipidemia' showing median percent changes from baseline in various lipid measures including total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, VLDL cholesterol, and non-HDL cholesterol across three treatment groups: Placebo, Simvastatin 40 mg/day, and Simvastatin 80 mg/day. Sample sizes for each group are 74.*

FDA Label Image

Figure 8 (Simvastatin 9)

A data table titled 'TABLE 7' presenting six-week median lipid-lowering effects of simvastatin in type III hyperlipidemia. It compares median change from baseline values (mg/dL) for total cholesterol, LDL-C, VLDL-C, and non-HDL-C among placebo and two simvastatin dosages (40 mg/day and 80 mg/day). Sample sizes, ranges, and median values are included.*

* 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.