Gemfibrozil Tablet
Product Images NDC 82804-221

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 82804-221). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

Additional Adverse Reactions (Additional Adv Drug Reactions)

Text table listing adverse reactions associated with GEMFIBROZIL 600 mg tablets. It categorizes conditions with 'Causal Relationship Probable' and 'Causal Relationship Not Established' across various systems including gastrointestinal, central nervous, eye, genitourinary, musculoskeletal, laboratory findings, hematopoietic, immunologic, and integumentary.*

FDA Label Image

Adverse Reactions (Adv Reactions)

A data table comparing the frequency of adverse events in subjects taking Gemfibrozil 600 mg tablets versus placebo. It lists gastrointestinal reactions, atrial fibrillation, and several other adverse events with their respective percentages in both groups.*

FDA Label Image

Struct (Structure Gemfibrozil)

Chemical structure of gemfibrozil, the active ingredient in GEMFIBROZIL 600 mg oral tablets by Proficient Rx LP.*

FDA Label Image

Table1 (Table 1)

A data table titled 'Table I' showing reduction in coronary heart disease (CHD) rates (events per 1000 patients) by baseline lipid levels from the Helsinki Heart Study over 0-5 years. It compares incidence of events between placebo and gemfibrozil groups across different lipid value categories, including all patients and subgroups defined by LDL-C, HDL-C, and triglyceride levels.*

FDA Label Image

Table2 (Table 2)

A data table titled 'Table II' presenting rates of cardiac events and all-cause mortality (events per 1000 patients) during a 3.5 year open-label follow-up in the Helsinki Heart Study. The table compares six patient groups categorized by treatment and attendance, showing event rates for cardiac events and all-cause mortality for each group.*

FDA Label Image

Table3 (Table 3)

A table titled "Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths, and All-Cause Mortality in the Helsinki Heart Study, Years 0-8.5". It compares event counts between Gemfibrozil and placebo groups at study start, along with hazard ratios and confidence intervals for cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality. Footnotes clarify analysis parameters and definitions of events.*

FDA Label Image

82804-221-90 (Image 01)

Label for Gemfibrozil 600 mg tablets, 90 count, manufactured by Ascent Pharmaceuticals, Inc. and packaged by Proficient Rx LP. The label shows the NDC 82804-221-90 and describes the tablets as white to off-white, film-coated, oval, debossed with "1" and partial bisects on both sides. Storage instructions and a barcode are also visible.*

* 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.