Argatroban Injection
Product Images NDC 83301-0062

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 83301-0062). 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 diagram of Argatroban, showing its molecular components including multiple ring structures, amide groups, and a sulfonamide moiety.*

FDA Label Image

Figure 1 (Argatroban 02)

A line graph depicting the relationship between infusion dose (mcg/kg/min) on the x-axis and coagulation measures aPTT (sec ± sem) and ACT (sec ± sem) on the y-axes, with plasma argatroban concentration (mcg/mL) indicated on the secondary x-axis. The graph shows that both aPTT and ACT increase with higher infusion doses of Argatroban injection.*

FDA Label Image

Figure 2 (Argatroban 03)

A scatter plot graph comparing INR Warfarin alone (x-axis) to INR Warfarin plus Argatroban (y-axis) in data from 24 subjects. Two trend lines are shown for Thromboplastin A (solid line, ISI 0.88) and Thromboplastin B (dashed line, ISI 1.78), with corresponding regression equations. Confidence error interval of ±0.4 units for prediction of Warfarin INR is noted.*

FDA Label Image

Figure 3 (Argatroban 04)

A line graph depicting Study 1 results comparing the proportion of event-free subjects over 35 days between Argatroban (N=160) and Historical Control (N=147). The y-axis represents the proportion event-free (0 to 1) and the x-axis represents study days (0 to 35). Argatroban shows a higher event-free proportion than Historical Control, with a p value of 0.007 indicating statistical significance.*

FDA Label Image

Figure 4 (Argatroban 05)

A line graph labeled "STUDY 1" showing the proportion of event-free participants over time (Study Day 0 to 35). Two lines represent Argatroban (solid line) and Historical Control (dotted line) groups, with corresponding sample sizes and censored counts noted. The graph includes a p-value of 0.018 comparing the two groups.*

FDA Label Image

Principal Display Panel (50 mL Vial Carton)

Label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) single dose vial. Includes warnings not to dilute prior to administration and to discard unused portion. Lists active ingredient amount per mL and storage instructions. Manufactured by Gland Pharma Limited, labeled for Mullan Pharmaceutical Inc.*

* 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.