Argatroban Solution
Product Images NDC 68083-141

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 68083-141). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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

Image1 (Argatroban 01)

Chemical structure of argatroban, showing its molecular composition including functional groups and bonds, with visualization of atoms such as nitrogen, oxygen, sulfur, and carbon in a detailed 2D diagram.*

FDA Label Image

Image2 (Argatroban 02)

A line graph showing the relationship between infusion dose (mcg/kg/min) and plasma Argatroban concentration (mcg/mL) with clotting times measured by aPTT (seconds) and ACT (seconds). Both clotting times increase with higher infusion doses, depicted with data points and error bars reflecting standard error of the mean.*

FDA Label Image

Image3 (Argatroban 03)

A scatter plot graph comparing INR Warfarin Alone (W) on the x-axis with INR Warfarin Plus Argatroban (WA) on the y-axis, showing data from 24 subjects. The graph includes two linear regression lines labeled Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78), with corresponding equations. It also mentions the prediction error confidence interval for Warfarin INR.*

FDA Label Image

Figure 3 (Argatroban 04)

A Kaplan-Meier survival curve graph showing the proportion of event-free patients over days of study for Argatroban compared to a historical control group. The y-axis represents the proportion event-free, while the x-axis shows study days from 0 to 35. The graph includes censored data points and a p-value of 0.007 indicating statistical comparison between groups.*

FDA Label Image

Figure4 (Argatroban 05)

A survival curve chart comparing the proportion event-free over study days between Argatroban treatment (N=144) and a historical control group (N=46). The chart shows event-free proportions declining over time, with Argatroban maintaining a higher proportion free of death, amputation, or new thrombosis events. A p value of 0.018 suggests statistical significance in this comparison.*

FDA Label Image

Image6 (Argatroban 06)

Label for Argatroban Injection in 0.9% Sodium Chloride, containing 125 mg per 125 mL (1 mg/mL) solution for intravenous infusion. The single-use vial label advises not to dilute before administration and to discard unused portions. The product is manufactured by Gland Pharma Limited, Hyderabad, India, with storage instructions and dosage information included.*

* 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.