Darzalex Iv Injection, Solution, Concentrate
Product Images NDC 57894-505

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Darzalex Iv (NDC 57894-505). 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 (Darzalex 01)

A Kaplan-Meier plot showing the proportion of patients surviving without progression over months for two treatment groups: D-Rd and Rd. The x-axis represents months, and the y-axis shows the proportion surviving without progression, ranging from 0 to 1. The chart includes number of patients at risk over time and a table summarizing median progression-free survival and hazard ratio between groups.*

FDA Label Image

Darzalex 01a

A Kaplan-Meier survival curve showing proportion surviving over months for two groups, D-Rd and Rd. The graph includes hazard ratio, median overall survival data, and number at risk table below the x-axis. The y-axis represents proportion surviving from 0.0 to 1.0, and the x-axis represents time in months from 0 to 72.*

FDA Label Image

Figure 2 (Darzalex 02)

A Kaplan-Meier survival curve graph showing the proportion of patients surviving without progression over time in months, comparing two treatments labeled D-VMP and VMP. The graph includes a table with median progression-free survival in months, hazard ratio, confidence interval, and patient numbers at risk over the study period.*

FDA Label Image

Principal Display Panel (100 mg/5 mL Vial Carton)

A Kaplan-Meier survival curve chart comparing the proportion surviving over time in months between two treatment groups, D-VMP and VMP. The chart includes data points for the number at risk for each group along the x-axis and a table with median overall survival and hazard ratio details. The y-axis represents the proportion surviving from 0 to 1.*

FDA Label Image

Darzalex 04

A Kaplan-Meier survival curve showing the proportion of patients surviving without progression over months. The chart compares two groups, D-VTd and VTd, with accompanying tables displaying the number of events, hazard ratio with confidence interval, p-value, and number of patients at risk over time.*

FDA Label Image

Darzalex 05

A Kaplan-Meier survival curve comparing progression-free survival between two treatment groups labeled DRd and Rd over approximately 21 months. The graph shows the proportion surviving without progression on the vertical axis and time in months on the horizontal axis. Below the curves is a summary table with median progression-free survival and hazard ratio data, with DRd showing longer survival without progression compared to Rd.*

FDA Label Image

Darzalex 06

A Kaplan-Meier survival curve depicting progression-free survival over 15 months comparing two regimens, labeled 'DVd' and 'Vd'. The y-axis represents the proportion surviving without progression, ranging from 0 to 1, and the x-axis shows time in months. The graph includes a risk table for each group below and summary statistics on median progression-free survival and hazard ratio.*

FDA Label Image

Darzalex 07

A Kaplan-Meier survival curve showing the proportion of patients surviving without progression over time in months. The chart compares two groups, D-Kd and Kd, with labeled lines and data points. Below the graph is a table reporting median progression-free survival and hazard ratio statistics for D-Kd versus Kd, along with the number of patients at risk at various time points.*

FDA Label Image

Darzalex 08

Packaging label for Darzalex IV (daratumumab) injection 100 mg/5 mL (20 mg/mL), a single-dose vial for intravenous infusion only. The label includes usage instructions, ingredient details, storage conditions, a barcode, and manufacturer information by Janssen Biotech, Inc.*

FDA Label Image

Darzalex 09

Darzalex IV (daratumumab) Injection 100 mg/5 mL (20 mg/mL) solution concentrate for intravenous use. The single-dose vial package label includes active ingredients, storage instructions, and manufacturer details Janssen Biotech, Inc. It states to dilute before use and store unopened vials refrigerated at 2° to 8°C. The label also shows barcodes, regulatory information, and dosage form.*

* 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.