Renflexis Injection, Powder, Lyophilized, For Solution
Product Images NDC 78206-162

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Renflexis (NDC 78206-162). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Organon 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

Figure 1 (Renflexis 01)

A line graph showing the percentage of patients who had not lost response over 54 study weeks comparing placebo maintenance, 5 mg/kg infliximab maintenance, and 10 mg/kg infliximab maintenance groups. The graph indicates a higher sustained response rate with infliximab dosing, with p-values noted for significance versus placebo.*

FDA Label Image

Figure 2 (Renflexis 02)

A line graph showing the percentage of patients who had not lost response over 54 study weeks. It compares two groups: placebo maintenance and 5 mg/kg infliximab maintenance. The x-axis represents study weeks, and the y-axis represents the percentage of patients. The graph indicates higher sustained response in the infliximab group with a statistically significant p-value of 0.001.*

FDA Label Image

Figure 3 (Renflexis 03)

A line graph depicting the proportion of patients (%) over 24 weeks comparing Infliximab 5 mg/kg versus placebo. The x-axis represents weeks (0 to 24), and the y-axis represents the proportion of patients (0% to 100%). Infliximab shows a higher patient response consistently across all time points, with significant differences noted (P<0.001).*

FDA Label Image

Figure 4 (Renflexis 04)

A line graph illustrating the percent of patients over a period of up to 50 weeks. The x-axis represents weeks, and the y-axis shows the percent of patients. The graph compares four groups of patients receiving infliximab at doses of 3 mg/kg or 5 mg/kg, administered either every 8 weeks or as needed (PRN). Different symbols and lines identify each dosing group, showing trends in patient percentages over time.*

FDA Label Image

Principal Display Panel (100 mg Vial Carton)

Packaging label for Renflexis (infliximab-abda) injection, 100 mg per vial, a lyophilized powder for intravenous infusion. The label shows it is distributed by Organon LLC, manufactured by Samsung Bioepis in Korea, and includes storage instructions, dosage form, and dilution guidance. The label emphasizes use as a single-dose vial and includes barcode and serialization panels.*

* 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.