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)

This is a description of Gemfibrozil tablets manufactured by Ascent Pharmaceuticals and distributed by Camber Pharmaceuticals. The tablets come in a bottle of 500 and should be stored at room temperature protected from light and humidity. Each tablet contains 600 mg of gemfibrozil. The label instructs to see the package insert for full prescribing information.*

FDA Label Image

Additional Adverse Reactions (Additional Adv Drug Reactions)

This appears to be a list of potential side effects associated with a drug or medication. It includes various physical and neurological symptoms such as weight loss, cardiac issues, gastrointestinal problems, central nervous system issues, decreased libido and depression. Additionally, it mentions possible side effects associated with vision, renal function, musculoskeletal health, hematopoietic health, and immunological system function, as well as potential issues with the integumentary system. It is likely that this text is intended for healthcare providers or pharmacists to reference.*

FDA Label Image

Adverse Reactions (Adv Reactions)

The given text is a comparison of the adverse events experienced by two groups of subjects, one receiving Gemfibrozil and the other receiving a placebo. The number of subjects in each group was 2046 and 2035 respectively. The table displayed in the text shows the frequency in percentage of subjects experiencing various side effects such as gastrointestinal reactions, dyspepsia, abdominal pain, acute appendicitis, and atrial fibrillation. Adverse events reported by more than 1% of subjects, but without significant difference between groups, were diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache.*

FDA Label Image

Struct (Structure Gemfibrozil)

FDA Label Image

Table1 (Table 1)

The text is a table showing the reduction in CHD rates by baseline lipids in the Helsinki Heart Study over the course of 0-5 years. The table has columns for all patients, LDL-C>175, HDL-C>46.4, LDL-C>175; HDL-C<35, and TG>200. The rows show the incidence of events in terms of P G Dif (difference in rates between placebo and gemfibrozil groups), with values for non-fatal myocardial infarctions plus sudden cardiac deaths (events per 1000 patients over years). There are also lipid values in mg/dL at baseline listed.*

FDA Label Image

Table2 (Table 2)

The table shows the cardiac events and all-cause mortality in six groups of patients during a 3.5 year open-label follow-up to the Helsinki Heart Study. The groups are classified by original randomization (placebo or gemfibrozil) and whether they attended the clinic or not. The table provides the number of patients in each group and the events per 1000 patients in each category.*

FDA Label Image

Table3 (Table 3)

The table shows cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality in the Helsinki Heart Study from years 0-8.5. The table compares the effects of gemfibrozil and placebo on the study participants. The intention-to-treat analysis was conducted on the originally randomized patients without considering open-label treatment switches and study conditions. The gemfibrozil:placebo group hazard ratio and confidence intervals are also mentioned for each event. The events monitored were fatal and non-fatal myocardial infarctions plus sudden cardiac deaths.*

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