Gemfibrozil Tablet
Product Images NDC 72865-186

7 FDA label images from Xlcare Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 72865-186). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, 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

600 mg- 500s (600 mg 500 Count)

600 mg- 500s (600 mg 500 Count)
Label for Gemfibrozil Tablets, USP 600 mg by XLCare Pharmaceuticals, Inc. The label includes the NDC 72865-186-05 and indicates the product is a prescription oral tablet. The package contains 500 tablets. Storage instructions recommend controlled room temperature and protection from light and humidity. Manufacturer information for Ascent Pharmaceuticals and XLCare Pharmaceuticals is also included.*
FDA Label Image

Additional Adv Reactions (Additional Adv Reactions)

Additional Adv Reactions (Additional Adv Reactions)
A table listing adverse reactions categorized by causality for the drug Gemfibrozil 600 mg tablets by XLCare Pharmaceuticals, Inc. It contrasts probable causal relationships with those not established, including effects across systems such as gastrointestinal, central nervous, musculoskeletal, hematopoietic, immunologic, and integumentary, among others.*
FDA Label Image

Adv Reactions (Adverse Reactions)

Adv Reactions (Adverse Reactions)
A data table comparing the frequency of adverse events between subjects taking Gemfibrozil 600 mg tablets and placebo. It lists gastrointestinal reactions, acute appendicitis, atrial fibrillation, and other adverse events with percentages for each group, highlighting events reported by more than 1% of subjects without significant differences between groups.*
FDA Label Image

Struct (Struct Gemfibrozil)

Struct (Struct Gemfibrozil)
Chemical structure diagram of Gemfibrozil, showing its molecular components including aromatic rings, methyl groups, and carboxylic acid functional group.*
FDA Label Image

Tab 1 (Tab 1)

Tab 1 (Tab  1)
A data table titled 'Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids in the Helsinki Heart Study, Years 0-5,' comparing cardiovascular event incidence between placebo and gemfibrozil groups. It shows patient counts and differences across lipid categories including LDL-C and HDL-C levels, with footnotes explaining lipid measurements and group definitions.*
FDA Label Image

Tab 2 (Tab 2)

Tab 2 (Tab  2)
A data table titled 'Table II' presenting cardiac events and all-cause mortality rates (events per 1000 patients) during 3.5 years of open-label follow-up in the Helsinki Heart Study. It compares multiple groups based on treatment and attendance, showing values for cardiac events and all-cause mortality for each group.*
FDA Label Image

Tab 3 (Tab 3)

Tab 3 (Tab  3)
A data table titled 'Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths, and All-Cause Mortality in the Helsinki Heart Study, Years 0-8.5' comparing events in patients taking Gemfibrozil versus placebo. The table includes numbers of cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality with hazard ratios and 95% confidence intervals contrasting Gemfibrozil and placebo groups, accompanied by footnotes explaining the analysis context.*

* 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.