Gemfibrozil
Product Images NDC 53217-251

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Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 53217-251). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals Llc, 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

Image (Gemfibrozil Usp 1)

FDA Label Image

Image (Gemfibrozil Usp 2)

Image (Gemfibrozil Usp 2)
The text is describing a table that shows the reduction in CHD rates (events per 1000 patients) by baseline lipids in the Helsinki Heart Study from Years 0 to 52. It includes information on lipid values, patients, and incidence of events, and there are two groups: the placebo group and the gemfibrozil tablets group. The table highlights the difference in rates between the placebo and the gemfibrozil group for fatal and nonfatal myocardial infarctions plus sudden cardiac deaths (events per 1000 patients over five years).*
FDA Label Image

Image (Gemfibrozil Usp 3)

Image (Gemfibrozil Usp 3)
This is a table showing the number of cardiac events and all-cause mortality occurring during the 3.5 year open-label follow-up to the Helsinki Heart Study. It includes six groups based on original randomization and follow-up drug taken. The numbers of patients in each group are listed.*
FDA Label Image

Image (Gemfibrozil Usp 4)

Image (Gemfibrozil Usp 4)
This is a table with data from the Helsinki Heart Study, monitoring cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality over an 8.5 year period in two groups - one group taking gemfibrozil and one taking a placebo. The intention-to-treat analysis was used, comparing the gemifibrozil group to the placebo group, excluding open-label treatment switches and exposure to study conditions. The table shows the number of events, the hazard ratio, and the corresponding confidence intervals for each type of mortality. There were no non-English characters detected.*
FDA Label Image

Image (Gemfibrozil Usp 5)

Image (Gemfibrozil Usp 5)
This text appears to be a list of potential side effects or symptoms associated with a medication, grouped into various categories such as Cardiac, Central Nervous System, and Clinical Laboratory. There's also a note about a caution or warning for rhabdomyolysis. Without knowing the context or specific medication this list pertains to, it's difficult to provide more detail.*
FDA Label Image

Package Label (Gemfibrozil Usp 6)

Package Label (Gemfibrozil Usp 6)
This is a medication labeled as Gemfibrozil, USP, which is the generic equivalent for Lopid. It is sold in 600mg tablets, which are white, oblong and scored with a G on one side and 225 on the other. The medication is packaged in a bottle containing 30 tablets with an NDC number of 53217-0251-30. The medication should be kept out of reach of children and should not be dispensed without a prescription due to federal law. The medication is manufactured by Invagen Pharmaceuticals, Inc. and the lot number is not visible in the text. The text provides some dosing instructions in both English and Spanish.*

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