Remicade Injection, Powder, Lyophilized, For Solution
Product Images NDC 57894-030

5 FDA label images from Janssen Biotech, Inc. · 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 Remicade (NDC 57894-030). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen Biotech, 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

Figure 1 (Remicade 01)

Figure 1 (Remicade 01)
A line graph depicting the percentage of patients who had not lost response over 54 weeks during a study comparing placebo maintenance with 5 mg/kg and 10 mg/kg Remicade maintenance. The graph shows higher sustained response rates for Remicade doses versus placebo, with statistical significance noted at p < 0.001 for 10 mg/kg and p = 0.004 for 5 mg/kg doses.*
FDA Label Image

Figure 2 (Remicade 02)

Figure 2 (Remicade 02)
A line graph comparing the percentage of patients who had not lost response over 54 study weeks between placebo maintenance (open circles) and 5 mg/kg REMICADE maintenance (filled circles). The graph shows higher sustained response rates for REMICADE, with data points plotted along study weeks on the x-axis and percent of patients on the y-axis. A statistical significance note (p = 0.001) highlights the comparison between groups.*
FDA Label Image

Figure 3 (Remicade 03)

Figure 3 (Remicade 03)
A line graph showing the proportion of patients (%) over 24 weeks comparing Remicade 5 mg/kg and placebo. The graph displays marked higher patient proportions for Remicade at multiple time points, with significance indicated at P<0.001. The x-axis represents weeks (0 to 24), and the y-axis represents the proportion of patients (0% to 100%).*
FDA Label Image

Figure 4 (Remicade 04)

Figure 4 (Remicade 04)
A line graph depicting the percentage of patients over time in weeks (2 to 50) across four treatment groups with infliximab. The groups include 3 mg/kg infliximab every 8 weeks, 3 mg/kg infliximab as needed (PRN), 5 mg/kg infliximab every 8 weeks, and 5 mg/kg infliximab PRN. The graph shows patient response trends for these dosing regimens.*
FDA Label Image

Principal Display Panel (100 mg Vial Carton)

Principal Display Panel (100 mg Vial Carton)
Remicade (infliximab) 100 mg per vial injection powder, lyophilized for solution intravenous use, in a single-dose vial. The carton includes dosing instructions, storage conditions, manufacturer Janssen Biotech, Inc., and barcodes. It advises on reconstitution and dilution before infusion, and that each patient must receive the enclosed Medication Guide.*

* 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.