Renagel
Product Images NDC 67544-656

5 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Renagel (NDC 67544-656). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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.

Product Images & Figures Index

FDA Label Image

Bottle Label 800mg (67544 656)

Bottle Label 800mg (67544 656)
The label for Renagel (Sevelamer HCl) displays the strength of 800mg with a total count of 2160 tablets. It includes storage instructions to keep the product between 20-25 degrees Celsius (68-77 degrees Fahrenheit) and warns to keep the tablets out of reach of children. The label lists the manufacturer as Genzyme Ireland Ltd. based in Waterford, Ireland, and states the product is repackaged by Aphena Pharma Solutions in Cookeville, TN. The label also includes NDC number 67544-0656-79 and barcodes on both sides.*
FDA Label Image

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)
FDA Label Image

Figure 1. Chemical Structure Of Sevelamer Hydrochloride (Renagel Figure 1)

Figure 1. Chemical Structure Of Sevelamer Hydrochloride (Renagel Figure 1)
Chemical structure of the active ingredient in Renagel, depicting a polymeric compound with multiple amine groups and hydrochloride components along the backbone.*
FDA Label Image

Figure 2. Percentage Of Patients (y-axis) Attaining A Phosphorus Reduction From Baseline (mg/dl) At Least As Great As The Value Of The X-axis. (Renagel Figure 2)

Figure 2. Percentage Of Patients (y-axis) Attaining A Phosphorus Reduction From Baseline (mg/dl) At Least As Great As The Value Of The X-axis. (Renagel Figure 2)
A graph depicting the percentage of patients with a reduction in serum phosphorus levels from baseline, comparing Sevelamer Hydrochloride to an active control. The X-axis shows reduction in serum phosphorus (mg/dL) ranging from -4 to 8, with annotations for worsened increase and improved reduction. The Y-axis indicates the percentage of patients with reduction values at or above specified levels from 0 to 100%.*
FDA Label Image

Figure 3. Mean Phosphorus Change From Baseline For Patients Who Completed 52 Weeks Of Treatment (Renagel Figure 3)

Figure 3. Mean Phosphorus Change From Baseline For Patients Who Completed 52 Weeks Of Treatment (Renagel Figure 3)
A line graph showing phosphorus change from baseline over a 52-week study period comparing two treatments: Sevelamer Hydrochloride and an active control. The x-axis represents study weeks from 0 to 52, and the y-axis represents phosphorus change from baseline ranging from -5 to 2. Data points for Sevelamer Hydrochloride are marked with black circles, and active control with red squares.*

* 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.