Nplate Injection, Powder, Lyophilized, For Solution
Product Images NDC 55513-221

5 FDA label images from Amgen, 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 Nplate (NDC 55513-221). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amgen, 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

Reconstitution And Dilution Of Nplate Single Dose Vials (Nplate 01)

Reconstitution And Dilution Of Nplate Single Dose Vials (Nplate 01)
A flowchart illustrating the reconstitution instructions for Nplate (romiplostim) injection. It asks if the calculated patient dose is less than 23 mcg. If yes, reconstitute with Sterile Water for Injection, USP, then dilute with 0.9% Sodium Chloride Injection, USP. If no, reconstitute Nplate with Sterile Water for Injection, USP only, with no dilution required.*
FDA Label Image

Figure 1 (Nplate 01a)

Figure 1 (Nplate 01a)
A line graph depicting bleeding event rate (%), rescue medication use rate (%), and median platelet count (x 10^9/L) over weeks of treatment up to 156 weeks. Bleeding event and rescue medication rates are plotted on the left y-axis (%) with different dashed lines, while median platelet count is plotted on the right y-axis as a solid line. The x-axis represents weeks of treatment from baseline to 156 weeks.*
FDA Label Image

Principal Display Panel (500 mcg Vial Carton)

Principal Display Panel (500 mcg Vial Carton)
Nplate 500 mcg/vial injection powder, lyophilized, for solution, romiplostim, by Amgen, Inc. The label indicates a single dose vial with instructions for reconstitution with 1.2 mL sterile water for injection to a concentration of 500 mcg/mL. Storage instructions specify refrigeration at 2-8°C and caution not to freeze or shake. The label emphasizes subcutaneous use only and includes a barcode and patent information.*
FDA Label Image

Principal Display Panel (125 mcg Vial Carton)

Principal Display Panel (125 mcg Vial Carton)
Nplate 125 mcg/vial lyophilized powder for injection (romiplostim), single-dose vial by Amgen Inc. The label includes reconstitution instructions with sterile water to achieve 125 mcg/0.25 mL concentration for subcutaneous use. Storage instructions specify refrigeration at 2°C to 8°C, protection from light, and warnings against freezing and shaking. The vial is to be used once with unused portions discarded.*
FDA Label Image

Principal Display Panel (250 mcg Vial Carton)

Principal Display Panel (250 mcg Vial Carton)
Nplate (romiplostim) 250 mcg/vial injection powder for solution is shown. The label indicates it is a single-dose vial for subcutaneous use, manufactured by Amgen, Inc. Storage instructions include refrigeration at 2°C to 8°C, with unopened vials permitted at room temperature up to 25°C for 30 days. The vial is to be reconstituted with 0.72 mL sterile water for injection.*

* 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.