Gemfibrozil Tablet
Product Images NDC 68071-1733

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 68071-1733). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

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This is a label containing information about a medication called Gemfibrozil 600mg, produced by NuCare Pharmaceuticals, Inc. It provides details such as the number of tablets in the container and a lot number. It also includes a warning to keep the medication away from children and to store at a controlled temperature. There is also information on how to report side effects to the FDA and to call a doctor for medical advice.*

FDA Label Image

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FDA Label Image

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The table shows the reduction in coronary heart disease rates per 1000 patients based on their baseline lipids. The study was conducted in the Helsinki Heart Study for 52 years. The patients were divided into two groups, one that received placebo and the other that took gemfibrozil tablets. The table shows the incidence of events for both groups, including fatal and nonfatal myocardial infarctions as well as sudden cardiac deaths over a period of 5 years. The table provides information on the lipid values in mg/dL at baseline.*

FDA Label Image

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This is a table showing the incidence of cardiac events and all-cause mortality in six different groups (designated by original randomization and drug taken during follow-up) during a 3.5 year open-label follow-up to the Helsinki Heart Study. The table includes the number of patients in each group (N) and the number of events per 1000 patients.*

FDA Label Image

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This is a table presenting data from the Helsinki Heart Study, covering the period of years 0 to 8.5. It pertains to cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality. The table presents event numbers, hazard ratios, and confidence intervals comparing Gemfibrozil to the placebo group, based on the intention-to-treat analysis. The study looks at fatal and non-fatal myocardial infarctions as well as sudden cardiac deaths over the period of 8.5 years.*

FDA Label Image

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This appears to be a list of potential side effects associated with a medication, with a mention of "CAUSAL RELATIONSHIP" but "PROBABLE NOT ESTABLISHED." The side effects listed are categorized by different systems in the body, including the cardiovascular, gastrointestinal, central nervous, genitourinary, musculoskeletal, clinical laboratory, hematopoietic, immunologic, and integumentary systems. Some of the potential side effects listed include weight loss, cardiac issues, confusion, paresthesia, decreased libido, depression, renal dysfunction, myopathy, anemia, and various skin reactions. The medication and its purpose are not mentioned.*

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