Gemfibrozil
Product Images NDC 53217-251

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 53217-251). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals 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

Image (Gemfibrozil Usp 1)

Chemical structure diagram of Gemfibrozil showing a benzene ring with two methyl groups and a side chain containing an ether linkage and a carboxyl group with adjacent methyl groups.*

FDA Label Image

Image (Gemfibrozil Usp 2)

A table titled 'Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids in the Helsinki Heart Study, Years 0-5' comparing incidence of cardiac events between placebo and gemfibrozil groups across patient lipid subgroups. It shows event rates and differences for all patients and for various LDL-C, HDL-C, and triglyceride baseline levels.*

FDA Label Image

Image (Gemfibrozil Usp 3)

A table titled 'Cardiac Events and All-Cause Mortality (events per 1000 patients) Occurring During the 3.5 Year Open-Label Follow-up to the Helsinki Heart Study.' It compares cardiac events and all-cause mortality rates across six groups involving placebo and gemfibrozil tablets with different attendance and drug intake scenarios.*

FDA Label Image

Image (Gemfibrozil Usp 4)

A data table titled 'Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths and All-Cause Mortality in the Helsinki Heart Study, Years 0-8.5,' showing comparisons between Gemfibrozil and placebo groups at study start. It lists event counts for cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality, alongside hazard ratios and confidence intervals for each event type.*

FDA Label Image

Image (Gemfibrozil Usp 5)

Data table listing adverse reactions for Gemfibrozil categorized by system organ class, divided into probable causal relationship and not established causal relationship columns. Categories include general, cardiac, gastrointestinal, central nervous system, eye, genitourinary, musculoskeletal, clinical laboratory, hematopoietic, immunologic, and integumentary adverse effects.*

FDA Label Image

Package Label (Gemfibrozil Usp 6)

Gemfibrozil USP 600 mg film-coated tablets, packaged by Aidarex Pharmaceuticals LLC. The label shows quantity of 30 tablets, described as white oblong tablets with scoring. The label includes manufacturer details (Invagen Pharmaceuticals, Inc., Hauppauge, NY) and multiple patient instruction sections with dosage intervals and times a day fields.*

* 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.