Gemfibrozil Tablet
Product Images NDC 70518-4305

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 70518-4305). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Additional Adverse Reactions (Additional Adv Drug Reactions)

A data table listing adverse reactions categorized by likelihood of causal relationship to the drug gemfibrozil. Columns differentiate reactions as 'Causal Relationship Probable' or 'Causal Relationship Not Established,' across various systems including general, cardiac, gastrointestinal, central nervous, eye, genitourinary, musculoskeletal, clinical laboratory, hematopoietic, immunologic, and integumentary.*

FDA Label Image

Adverse Reactions (Adv Reactions)

A data table comparing the frequency percent of various adverse events in subjects treated with Gemfibrozil (N=2046) versus placebo (N=2035). The table lists gastrointestinal reactions, atrial fibrillation, and other adverse events with their respective percentages, highlighting differences between Gemfibrozil and placebo groups.*

FDA Label Image

Remedy_label (Remedy Label)

GEMFIBROZIL 600 mg oral tablet packaging label showing quantity of 180 tablets. The label indicates the product is RX only and includes the NDC 70518-4305-00. Manufactured by Camber Pharma, Inc., with repackaging by RemedyRepack Inc. Storage instructions are given to protect from light and humidity, storing between 20-25°C (68-77°F).*

FDA Label Image

Struct (Structure Gemfibrozil)

Chemical structure diagram of Gemfibrozil, showing the molecular arrangement including benzene ring with methyl substitutions and the side chain with carboxyl group as depicted in the image. This corresponds to the active ingredient in the GEMFIBROZIL 600 mg tablet by RemedyRepack Inc.*

FDA Label Image

Table1 (Table 1)

A data table titled 'Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids in the Helsinki Heart Study, Years 0-5'. It compares incidence of cardiovascular events between placebo and gemfibrozil groups across different baseline lipid subgroups, including LDL-C and HDL-C values, highlighting differences in event rates over 5 years.*

FDA Label Image

Table2 (Table 2)

Table II presenting rates of cardiac events and all-cause mortality per 1000 patients during a 3.5-year open-label follow-up to the Helsinki Heart Study. It shows event rates by six patient groups defined by randomization and drug intake status, comparing placebo and gemfibrozil groups with attendance variations during follow-up.*

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' comparing counts of events in gemfibrozil and placebo groups at study start, along with hazard ratios and confidence intervals for various cardiac and mortality events.*

* 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.