Simvastatin
Product Images NDC 43353-768

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 43353-768). 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, Inc., 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

Bottle Label (43353 768)

Simvastatin is a drug available in tablet form, with a dosage of 80mg for a box containing 15 tablets. The box has a batch number of "2 PO Ex=3 Z", while the product numbers are N 43353-0768-1 and NDC# 43353-0768-15. The tablets must be stored at a controlled room temperature of 20-25°C, away from minors, and in a container that complies with USP standards. The manufacturer is Blu Caribe located in Dorado, PR, while Aphena Pharma from Cookeville, TN, is the repackager.*

FDA Label Image

Bottle Label (43353 773)

Simvastatin is a medication presented in a pack of 15 tablets, with a strength of 20mg each. The tablets should be stored at a temperature between 20-25 degrees Celsius and kept out of reach of children. The drug was manufactured by Blu Caribe in Dorado, PR, and repackaged by Aphena Pharma in Cookesville, TN 38506. The batch number is N4335307731, with NDC# 43353-0773-15. No additional information is available.*

FDA Label Image

Image Of Chemical Structure (Simvastatin 1)

FDA Label Image

The Effects Of Treatment With Simvastatin On Major Vascular Events And Major Coronary Events In Hps (Simvastatin 2)

This is a statistical report of a medical study with a total of 20,536 patients, out of which 14,573 did not have diabetes mellitus. The report includes the incidence of major vascular events and major coronary events, as well as the LDL and HDL cholesterol levels of the patients in different subgroups. The study compares the use of Simvastatin versus Placebo and presents the risk ratios for each. The report contains triangles that show the point estimates of the relative risk and their 95% confidence intervals.*

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