Gemfibrozil Tablet
Product Images NDC 68071-2387

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 68071-2387). 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

Pdp (68071 2387 8)

Label for Gemfibrozil 600 mg tablets by NuCare Pharmaceuticals, Inc. The label indicates a package size of 180 tablets. It notes the dosage form as oval, white to off-white tablets with two partial bisects and a debossed '1'. The label includes storage instructions to keep at 68-77°F and warnings to keep out of reach of children. NDC code 68071-2387-8 is displayed along with product numbers and batch details.*

FDA Label Image

Additional Adverse Reactions (Additional Adv Drug Reactions)

A data table presenting adverse reactions associated with GEMFIBROZIL (gemfibrozil) tablets. It categorizes events by body system and separates them into two columns: those with a probable causal relationship and those where the relationship is not established. Categories include general, cardiac, gastrointestinal, central nervous system, eye, genitourinary, musculoskeletal, clinical laboratory, hematopoietic, immunologic, and integumentary reactions.*

FDA Label Image

Adverse Reactions (Adv Reactions)

A data table comparing the frequency of adverse events in subjects taking Gemfibrozil versus a placebo. It lists gastrointestinal reactions such as dyspepsia, abdominal pain, and acute appendicitis, along with atrial fibrillation. Additional adverse events reported by more than 1% of subjects, including diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache, are also shown with their respective percentages for both groups.*

FDA Label Image

Struct (Structure Gemfibrozil)

Chemical structure of gemfibrozil showing a benzene ring with two methyl groups and a side chain containing an ether linkage and a carboxylic acid group.*

FDA Label Image

Table1 (Table 1)

A table titled 'Reduction in CHD Rates (events per 1000 patients) by Baseline Lipids in the Helsinki Heart Study, Years 0-5' showing incidence of cardiovascular events comparing placebo and gemfibrozil groups across different lipid baseline values. Details include event counts per 1000 patients and differences between groups for categories of All Patients, LDL-C > 175 with HDL-C > 46.4, LDL-C > 175 with TG > 177, and LDL-C > 175 with TG > 200 and HDL-C < 35.*

FDA Label Image

Table2 (Table 2)

A data table titled 'Cardiac Events and All-Cause Mortality (events per 1000 patients) Occurring During the 3.5 Year Open-Label Follow-up to the Helsinki Heart Study.' It presents six groups designated by original randomization and drug intake status, reporting rates of cardiac events and all-cause mortality per 1000 patients for each group during the follow-up period.*

FDA Label Image

Table3 (Table 3)

Data table presenting cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality over 8.5 years in the Helsinki Heart Study comparing gemfibrozil and placebo groups. It includes event counts at study start, 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.