Gemfibrozil Tablet
Product Images NDC 68788-7964

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 68788-7964). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Preferred 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

Additional Adverse Reactions (Additional Adv Drug Reactions)

A table listing adverse reactions associated with Gemfibrozil. It categorizes reactions by system organ class and indicates those with probable causal relationship versus those where the causal relationship is not established. Reactions include dizziness, cholestatic jaundice, myopathy, and anaphylaxis among others.*

FDA Label Image

Adverse Reactions (Adv Reactions)

A table comparing the frequency of adverse events between subjects taking Gemfibrozil (N=2046) and Placebo (N=2035). It lists gastrointestinal reactions such as dyspepsia, abdominal pain, and acute appendicitis, as well as other events like atrial fibrillation, diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache, presented as percentages for each group.*

FDA Label Image

Gemfibrozol Tab. Usp 600mg

Packaging label for GEMFIBROZIL 600 mg oral tablets by Preferred Pharmaceuticals, Inc. The label indicates the generic name Gemfibrozil 600 mg, manufactured by Camber Pharmaceuticals, Inc., Piscataway, NJ. It displays lot, batch, expiration date fields, and cautions about storage and federal transfer law. Directions for use are shown in English and Spanish on a yellow background.*

FDA Label Image

Struct (Structure Gemfibrozil)

Chemical structure of Gemfibrozil, showing its molecular arrangement including a benzene ring with two methyl groups, an ether linkage, and a carboxylic acid group.*

FDA Label Image

Table1 (Table 1)

Table presenting reduction in coronary heart disease (CHD) event rates per 1000 patients over 5 years in the Helsinki Heart Study. It compares incidence of events between placebo and Gemfibrozil groups across baseline lipid subgroups, including all patients, LDL cholesterol >175 with HDL cholesterol >46.4, LDL cholesterol >175 with triglycerides >177, and LDL cholesterol >175 with triglycerides >200 and HDL cholesterol <35.*

FDA Label Image

Table2 (Table 2)

A data table titled 'Table II' showing cardiac events and all-cause mortality rates (events per 1000 patients) over 3.5 years of open-label follow-up in the Helsinki Heart Study. It compares six groups labeled PDrop, PN, PG, GDrop, GN, and GG, with patient counts and respective event rates for cardiac events and all-cause mortality. Footnotes explain group designations based on original randomization to placebo or Gemfibrozil and treatment status during follow-up.*

FDA Label Image

Table3 (Table 3)

Table presenting cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality in the Helsinki Heart Study over 0 to 8.5 years. It compares the number of events at study start for gemfibrozil and placebo groups, showing hazard ratios and confidence intervals for gemfibrozil versus placebo.*

* 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.