Argatroban Injection
Product Images NDC 0143-9377

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 0143-9377). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals 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

Arg Chem Structure (Argatroban Injection Novaplus 1)

Chemical structure of Argatroban, an active pharmaceutical ingredient. The diagram shows the molecular arrangement and bonds specific to Argatroban, a drug used in intravenous injection form.*

FDA Label Image

Figure 1 (Argatroban Injection Novaplus 2)

A graph depicting the relationship between infusion dose (mcg/kg/min) on the x-axis and plasma argatroban concentration (mcg/mL) on the top x-axis, along with activated partial thromboplastin time (aPTT) in seconds on the left y-axis and activated clotting time (ACT) in seconds on the right y-axis. The chart shows increasing trends of aPTT and ACT with rising infusion doses of argatroban.*

FDA Label Image

Figure 2 (Argatroban Injection Novaplus 3)

A scatter plot graph comparing INR Warfarin Plus Argatroban (WA) versus INR Warfarin Alone (W) based on data from 24 subjects. It includes two linear regression lines labeled Thromboplastin A (ISI=0.88) and Thromboplastin B (ISI=1.78) with corresponding equations, displaying the relationship between the two INR measurements and an error confidence interval annotation regarding the prediction of Warfarin INR.*

FDA Label Image

Figure 3 (Argatroban Injection Novaplus 4)

A Kaplan-Meier curve comparing the proportion of event-free subjects over a 35-day study period between Argatroban (N=160) and a historical control group (N=147). The chart shows two survival curves with the proportion event-free on the y-axis and study days on the x-axis, indicating differences in outcomes between the groups with a p value of 0.007.*

FDA Label Image

Figure 4 (Argatroban Injection Novaplus 5)

A Kaplan-Meier survival curve graph labeled Study 1 comparing event-free proportions over study days between Argatroban (N=144) and a Historical Control group (N=46). The graph shows the proportion event-free on the y-axis and study days on the x-axis, including a p-value of 0.018 indicating statistical comparison.*

FDA Label Image

Novaplus Container (Argatroban Injection Novaplus 6)

Label for Argatroban Injection 50 mg/50 mL (1 mg/mL) by Hikma Pharmaceuticals USA Inc. The label indicates the product is for intravenous infusion only, single dose vial of 50 mL. It includes storage instructions, usage warnings, and manufacturer information.*

FDA Label Image

Novaplus Carton (Argatroban Injection Novaplus 7)

The packaging label for Argatroban Injection 50 mg/50 mL (1 mg/mL) intravenous injection. The label indicates it is a 50 mL single dose vial with instructions to discard unused portions and not to dilute prior to administration. Manufactured by Exela Pharma Sciences, LLC and distributed by Hikma Pharmaceuticals USA Inc. The label lists inactive ingredients and storage conditions, and includes warnings about solution clarity and preservative content. The label features the Novaplus logo.*

FDA Label Image

Layout 2 (Argatroban Injection Novaplus 8)

Label panel for Argatroban injection, 50 mg/50 mL, by Hikma Pharmaceuticals USA Inc. The image shows a lot number, expiration date, GTIN barcode, and a serial number for product identification.*

* 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.