Gemfibrozil Tablet
Product Images NDC 31722-128

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 31722-128). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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

600 mg- 500s Count (600 mg)

Label for Gemfibrozil Tablets, USP 600 mg by Camber Pharmaceuticals, Inc. The label indicates a package size of 500 tablets and states Rx Only. It includes storage instructions, dosage note referring to package insert, and manufacturing details by Ascent Pharmaceuticals and Camber Pharmaceuticals. The NDC is 31722-128-05.*

FDA Label Image

Additional Adverse Reactions (Additional Adv Drug Reactions)

A table listing adverse reactions categorized by likelihood of causal relationship for a drug, divided into 'Causal Relationship Probable' and 'Causal Relationship Not Established' columns. The listing is organized by system categories including general, cardiac, gastrointestinal, central nervous system, eye, genitourinary, musculoskeletal, clinical laboratory, hematopoietic, immunologic, and integumentary reactions.*

FDA Label Image

Adverse Reactions (Adv Reactions)

A table showing the frequency percent of various adverse events in subjects treated with Gemfibrozil (N=2046) compared to placebo (N=2035). It lists gastrointestinal reactions (such as dyspepsia and abdominal pain), acute appendicitis, atrial fibrillation, and other events like diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache, with percentages for each group.*

FDA Label Image

Struct (Structure Gemfibrozil)

Chemical structure of Gemfibrozil, the active ingredient in GEMFIBROZIL 600 mg oral tablets. The diagram shows the molecular arrangement characteristic of Gemfibrozil, highlighting aromatic and aliphatic groups.*

FDA Label Image

Table1 (Table 1)

Table titled 'Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids in the Helsinki Heart Study, Years 0–5' showing incidence of events for different patient groups. Columns differentiate LDL-C and HDL-C levels, comparing placebo and gemfibrozil groups with their differences in event rates.*

FDA Label Image

Table2 (Table 2)

A data table titled 'Table II' presenting cardiac events and all-cause mortality rates per 1000 patients during a 3.5-year open-label follow-up in the Helsinki Heart Study. The table compares six groups identified by treatment categories and attendance, listing the number of patients per group and rates of cardiac events and all-cause mortality.*

FDA Label Image

Table3 (Table 3)

A data table titled 'Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths, and All-Cause Mortality in the Helsinki Heart Study, Years 0-8.5' comparing numbers of events for Gemfibrozil versus placebo groups. The table shows event counts at study start, hazard ratios, and confidence intervals for cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality, with footnotes explaining study conditions and definitions.*

* 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.