Argatroban Injection
Product Images NDC 83301-0500

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 83301-0500). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mullan Pharmaceutical 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

Chemical Structure (Argatroban 01)

Chemical structure of argatroban, depicted as a molecular diagram showing its detailed atomic connections including functional groups and stereochemistry.*

FDA Label Image

Figure 1 (Argatroban 02)

A chart showing the relationship between infusion dose (mcg/kg/min) on the x-axis and plasma Argatroban concentration (mcg/mL) with aPTT (sec; ± sem) on the left y-axis and ACT (sec; ± sem) on the right y-axis. The graph depicts increasing values for plasma Argatroban, aPTT, and ACT with increasing infusion dose up to 10 mcg/kg/min.*

FDA Label Image

Figure 2 (Argatroban 03)

A scatter plot graph showing the relationship between INR Warfarin Alone and INR Warfarin Plus Argatroban (WA) based on data from 24 subjects. It includes two regression lines representing Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78) with their respective equations. The graph also indicates prediction error and confidence intervals associated with Warfarin INR.*

FDA Label Image

Figure 3 (Argatroban 04)

A survival curve graph labeled 'STUDY 1' showing comparison of the proportion event-free over study days for Argatroban (N=160) versus Historical Control (N=147). The y-axis represents the proportion event-free from 0 to 1, and the x-axis shows study days from 0 to 35. The Argatroban curve remains higher than the Historical Control curve. A p value of 0.007 is indicated on the graph.*

FDA Label Image

Figure 4 (Argatroban 05)

A line graph titled 'STUDY 1' comparing the proportion of event-free subjects over study days for Argatroban (N=144) versus a historical control group (N=46). The y-axis shows proportion event-free, ranging from 0 to 1, and the x-axis shows study days from 0 to 35. Argatroban group's curve remains higher than the control, with a p-value of 0.018 indicated on the graph.*

FDA Label Image

Principal Display Panel (50 mL Vial Carton)

Packaging label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) from Mullan Pharmaceutical Inc. The label indicates it is for intravenous infusion only and contains instructions such as not to dilute prior to administration and to discard unused portions. The container size is a 50 mL single dose vial. The label also lists inactive ingredients and storage conditions, with a barcode and NDC 83301-0500-1 visible.*

FDA Label Image

Novaplus Logo (Argatroban 07)

* 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.