Uplizna Injection
Product Images NDC 75987-150

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Uplizna (NDC 75987-150). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Horizon Therapeutics Usa, 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 (Uplizna 01)

A Kaplan-Meier survival curve chart depicting relapse-free probability over days for UPLIZNA (inebilizumab) versus placebo. The chart compares relapse-free rates for patients on UPLIZNA and placebo from day 1 to day 225, showing higher relapse-free probability for UPLIZNA. It includes risk table counts and statistical data such as hazard ratio, number of events, and p-value.*

FDA Label Image

Figure 2 (Uplizna 02)

UPLIZNA 10 mg/mL injection label showing packaging for intravenous use. The label states the product contains 3 single-dose vials with 100 mg per 10 mL (10 mg/mL) of inebilizumab-cdon. It includes storage instructions at 2°C to 8°C, dilution requirements, manufacturer Horizon Therapeutics Ireland, and distributor Horizon Therapeutics USA, Inc. The NDC 75987-150-03 and barcode are visible with pharmacist dispensing instructions and Horizon logo.*

FDA Label Image

Figure 3 (Uplizna 02a)

A line graph comparing change from baseline in MG-ADL score over time (days) between UPLIZNA and placebo groups. The x-axis shows time points from day 1 to 183, and the y-axis shows change in MG-ADL score. Two lines depict mean scores with standard error bars: UPLIZNA (solid line) showing greater score reduction over time, and placebo (dashed line) with less reduction. Patient numbers at each time point are listed below the x-axis.*

FDA Label Image

Figure 4 (Uplizna 02b)

A line graph showing change from baseline in QMG score over time (days) comparing UPLIZNA (inebilizumab) and placebo groups. The graph plots mean scores with standard error bars at multiple time points up to 183 days, with UPLIZNA showing a greater decrease in QMG score than placebo. The number of subjects in each group is shown below the x-axis at each time point.*

FDA Label Image

Principal Display Panel (100 mg/10 mL Vial Label)

Label for UPLIZNA injection, 10 mg/mL (100 mg/10 mL) single-dose vial containing inebilizumab-cdon. The label indicates the product is for intravenous infusion after dilution, includes storage instructions, preparation details, and a barcode. Manufactured by Horizon Therapeutics USA, Inc.*

FDA Label Image

Principal Display Panel (100 mg/10 mL Vial Carton)

UPLIZNA injection 100 mg/10 mL (10 mg/mL) label for intravenous infusion. Contains 3 single-dose vials per carton. Manufactured by Horizon Therapeutics Ireland, DAC Dublin, Ireland. The label includes dosage preparation instructions and storage conditions, with branding and regulatory information from Amgen.*

* 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.