Sarclisa Injection, Solution, Concentrate
Product Images NDC 0024-0656

4 FDA label images from Sanofi-aventis U.s. Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Sarclisa (NDC 0024-0656). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sanofi-aventis U.s. 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 (Sarclisa 01)

Figure 1 (Sarclisa 01)
A Kaplan-Meier survival curve illustrating progression-free survival (PFS) probability over 16 months for patients treated with Sarclisa (isatuximab) plus Pd versus Pd alone. The graph shows higher PFS probability for the Isa-Pd group compared to Pd. Below is a table of patients at risk over time for each group.*
FDA Label Image

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

Principal Display Panel (100 mg/5 mL Vial Carton)
A Kaplan-Meier plot showing progression-free survival (PFS) probability over 24 months in patients treated with Isa-Kd versus Kd. The x-axis represents time in months, and the y-axis shows PFS probability. A table below summarizes median months, hazard ratio, and number of patients at risk for each treatment group.*
FDA Label Image

Principal Display Panel (500 mg/25 mL Vial Carton)

Principal Display Panel (500 mg/25 mL Vial Carton)
Packaging label for Sarclisa (isatuximab-irfc) Injection, 100 mg/5 mL (20 mg/mL) concentrate for intravenous infusion after dilution. The label indicates a single-dose vial with no preservative and instructions for storage and handling. Manufactured by Sanofi-Aventis U.S. LLC, Bridgewater, NJ. NDC 0024-0654-01 is visible.*
FDA Label Image

Sarclisa 04

Sarclisa 04
Packaging label for Sarclisa (isatuximab-irfc) injection concentrate, 500 mg/25 mL (20 mg/mL) strength. The label indicates the product is for intravenous infusion after dilution and includes one single-dose vial. The labeler is Sanofi-Aventis U.S. LLC. The label also provides storage instructions and list of inactive ingredients.*

* 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.