Argatroban Injection, Solution
Product Images NDC 25021-414

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 25021-414). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sagent Pharmaceuticals, 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

Structural Formula (Arg06 0000 01)

Chemical structure diagram of Argatroban, the active ingredient in the product Argatroban injection, solution. The structure includes labeled atoms and bonds representing the molecular configuration of Argatroban along with a water molecule (H2O).*

FDA Label Image

Figure 1 (Arg06 0000 02)

A line graph illustrating the relationship at steady state between Argatroban dose (infusion dose in mcg/kg/min), plasma Argatroban concentration (mcg/mL), and anticoagulant effect. The primary y-axis on the left shows aPTT in seconds, increasing with dose, while the secondary y-axis on the right shows INR, also rising with increased infusion dose.*

FDA Label Image

Figure 2 (Arg06 0000 03)

A scatter plot graph titled 'INR Relationship of Argatroban Plus Warfarin Versus Warfarin Alone' showing data from 24 subjects. The x-axis represents INR Warfarin Alone (W) values, and the y-axis represents INR Warfarin Plus Argatroban (WA) values. The graph includes two trend lines labeled Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78), with corresponding linear equations and confidence intervals related to warfarin INR prediction error (± 0.4 units).*

FDA Label Image

Figure 3 (Arg06 0000 04)

A Kaplan-Meier curve showing the proportion of event-free patients over a 35-day study period in Study 1. The graph compares Argatroban (N=160) versus Historical Control (N=147), with event-free proportions decreasing over time. A p-value of 0.007 indicates statistical comparison between the groups.*

FDA Label Image

Figure 4 (Arg06 0000 05)

A Kaplan-Meier survival curve comparing Argatroban and Historical Control groups over a 35-day study period. The vertical axis shows the proportion event-free, and the horizontal axis shows study days. The graph includes sample sizes and censored event counts for each group, and a reported p-value of 0.018.*

FDA Label Image

Package Label – Principal Display Panel – Vial Label (Arg06 0000 06)

Label for Argatroban Injection 1 mg/mL (50 mg per 50 mL) intravenous infusion, supplied in a 50 mL single-dose vial. The label states it is for intravenous infusion only and to discard unused portions. Manufactured by Sagent Pharmaceuticals, the label includes storage instructions and a note that it is sterile and nonpyrogenic.*

* 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.