Gemfibrozil Tablet
Product Images NDC 63187-772

6 FDA label images from Proficient Rx Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 63187-772). 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

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Chemical structure of Gemfibrozil, shown as a molecular diagram with a benzene ring substituted with two methyl groups and connected through an ether linkage to a carboxylic acid functional group with additional methyl substituents.*
FDA Label Image

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A data table titled 'Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids in the Helsinki Heart Study, Years 0-5', comparing incidence of events between placebo and gemfibrozil tablet groups across various baseline lipid categories. The table includes footnotes explaining lipid values units, group definitions, and event types measured.*
FDA Label Image

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Table II presents cardiac events and all-cause mortality rates per 1000 patients over a 3.5-year open-label follow-up in the Helsinki Heart Study. It compares six groups based on randomized assignment and drug intake status, including placebo and gemfibrozil tablets, with patient counts and event occurrence rates listed for each group.*
FDA Label Image

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A data table titled 'Table III Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths and All-Cause Mortality in the Helsinki Heart Study, Years 0-8.5.' The table compares events between Gemfibrozil and placebo groups, showing counts for cardiac events, cardiac deaths, non-cardiac deaths, all-cause mortality, along with hazard ratios and confidence intervals. Footnotes clarify study conditions and hazard ratio interpretation.*
FDA Label Image

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A table listing adverse reactions categorized by causal relationship probability for Gemfibrozil. It organizes side effects into 'Causal Relationship Probable' and 'Causal Relationship Not Established' columns, covering systems including general, cardiac, gastrointestinal, central nervous system, eye, genitourinary, musculoskeletal, clinical laboratory, hematopoietic, immunologic, and integumentary.*
FDA Label Image

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63187-772-30 (94ab25ac 72da 447a Ae3c 6343a5e46f59 06)
Gemfibrozil 600 mg tablets label from Proficient Rx LP. The label states each white film-coated, capsule-shaped, biconvex tablet contains 600 mg of gemfibrozil and is debossed with '1' and 'G' on one side and '225' on the other. The label includes product ID RG077260 and manufacturer information for InvaGen Pharmaceuticals, Inc. It indicates a controlled room temperature storage requirement and is marked RX Only.*

* 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.