Infliximab Injection, Powder, Lyophilized, For Solution
Product Images NDC 57894-160

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 Infliximab (NDC 57894-160). 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 (Infliximab 01)

Figure 1 (Infliximab 01)
A line graph showing the percentage of patients who had not lost response over 54 study weeks. It compares placebo maintenance, 5 mg/kg infliximab maintenance, and 10 mg/kg infliximab maintenance, with 10 mg/kg showing the highest retention of response and placebo the lowest. Statistical significance values are noted for infliximab doses versus placebo.*
FDA Label Image

Figure 2 (Infliximab 02)

Figure 2 (Infliximab 02)
A line graph comparing the percentage of patients who had not lost response over a 54-week study period between placebo maintenance and 5 mg/kg infliximab maintenance. The y-axis shows the percentage of patients, and the x-axis represents study weeks from 0 to 54. The graph includes two lines: one for placebo maintenance and one for infliximab maintenance, demonstrating statistically significant differences between the groups (p=0.001).*
FDA Label Image

Figure 3 (Infliximab 03)

Figure 3 (Infliximab 03)
A line graph comparing the proportion of patients (%) over 24 weeks between two groups: Placebo and Infliximab 5 mg/kg. The graph shows higher patient proportions in the infliximab group at each time point, with statistically significant differences marked by asterisks (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 (Infliximab 04)

Figure 4 (Infliximab 04)
Line graph depicting the percent of patients over 50 weeks receiving different Infliximab dosing regimens. The x-axis shows weeks from 2 to 50, and the y-axis shows percent of patients from 0 to 100%. Four data series represent 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 as needed (PRN), with corresponding patient numbers noted in the legend.*
FDA Label Image

Principal Display Panel (100 mg Vial Box)

Principal Display Panel (100 mg Vial Box)
Box packaging label for Infliximab injection, 100 mg per vial, lyophilized powder for solution, intended for intravenous use. Manufactured by Janssen Biotech, Inc. Label includes dosage instructions, storage conditions, barcode, and product identification details including NDC 57894-160-01.*

* 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.