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.

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Additional Adverse Reactions (Additional Adv Drug Reactions)

This text appears to list possible side effects and symptoms related to a medication or medical condition, including weight loss, cardiac issues, gastrointestinal issues, central nervous system problems, eye problems, genitourinary issues, musculoskeletal symptoms, clinical laboratory findings, hematopoietic symptoms, immunologic reactions, integumentary issues, and pruritus. These symptoms may occur but a causal relationship is not clearly established.*

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Adverse Reactions (Adv Reactions)

This is a comparison table of adverse events between gemfibrozil and a placebo. Gemfibrozil showed a lower frequency of gastrointestinal reactions, dyspepsia, abdominal pain, acute appendicitis (histologically confirmed), and atrial fibrillation compared to the placebo group. Adverse events reported by more than 1% of subjects without a significant difference between groups include diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache.*

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Struct (Structure Gemfibrozil)

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Table1 (Table 1)

This text provides information on the reduction in coronary heart disease (CHD) rates in the Helsinki Heart Study based on baseline lipid levels. The data includes the incidence of events per 1000 patients over a 5-year period for different lipid categories. It compares the rates between the placebo and gemfibrozil groups, focusing on fatal and non-fatal myocardial infarctions and sudden cardiac deaths.*

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Table2 (Table 2)

This is a table evaluating Cardiac Events and All-Cause Mortality rates (events per 1000 patients) during a 3.5-year open-label follow-up to the Helsinki Heart Study. The data includes information on different groups such as PDrop, PN, PG, GDrop, GN, and GG. The table shows the number of patients in each group (N=215, N=494, N=1283, N=221, N=574, N=1207) and the corresponding rates of Cardiac Events and All-Cause Mortality for each group. The designations for the six open-label groups are explained in a note at the end of the table.*

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Table3 (Table 3)

This text provides a comparison of cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality in the Helsinki Heart Study over years 0-8.5 for patients receiving Gemfibrozil versus Placebo. It includes hazard ratios and confidence intervals for different events. The study focuses on the intention-to-treat analysis of the originally randomized patients without considering open-label treatment switches or exposure to study conditions. The data also mentions fatal and non-fatal myocardial infarctions and sudden cardiac deaths over an 8.5-year period.*

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82804-221-90 (Image 01)

This is a prescription medication called Gemfibrozil 600mg, which comes in the form of oval tablets with a white to off-white color. Each tablet contains 600 mg of gemfibrozil. It is manufactured by Ascent Pharmaceuticals, Inc. and distributed by Proficient Rx LP. The medication should be stored at controlled room temperature and kept out of the reach of children. The packaging includes information such as lot number, serial number, expiration date, and product identification number.*

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