Argatroban Injection, Solution
Product Images NDC 67457-212

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 67457-212). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Institutional Llc, 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

Argatroban Injection 250 mg/2.5 mL Carton Label (Image 01)

Packaging label for Argatroban Injection 250 mg/2.5 mL (100 mg/mL) sterile solution for intravenous infusion by Mylan Institutional LLC. The label indicates a single-dose vial with instructions to dilute prior to use. It includes storage information, preservative-free status, ingredients, and barcode data.*

FDA Label Image

Figure 1: Relationship At Steady-state Between Argatroban Dose, Plasma Argatroban Concentration And Anticoagulant Effect (Image 02)

A line graph illustrating the relationship between infusion dose (mcg/kg/min) on the x-axis and two variables, aPTT (sec ± sem) and ACT (sec ± sem), on the y-axes. The graph shows an increasing trend in both aPTT and ACT values as the infusion dose increases, with aPTT values represented by black squares and ACT values by open circles.*

FDA Label Image

Figure 2: Inr Relationship Of Argatroban Plus Warfarin Versus Warfarin Alone (Image 03)

A scatter plot comparing INR Warfarin Alone (W) on the horizontal axis with INR Warfarin Plus Argatroban (WA) on the vertical axis. The graph includes two regression lines for Thrombolastin A and B with their respective ISI values, equations, and an error confidence interval ±0.4 Units associated with Warfarin INR prediction from data collected from 24 subjects.*

FDA Label Image

Figure 3: Time To First Event For The Composite Efficacy Endpoint: Hit Patients (Image 04)

A line graph titled Study 1 showing the proportion of event-free subjects over study days for Argatroban compared to a historical control group. The y-axis represents the proportion event-free from 0 to 1, and the x-axis shows study days from 0 to 35. Two curves illustrate survival probabilities with a significant p value of 0.007. Censored data points are noted for both groups.*

FDA Label Image

Figure 4: Time To First Event For The Composite Efficacy Endpoint: Hitts Patients (Image 05)

A Kaplan-Meier survival curve titled 'STUDY 1' showing proportion event-free over study days for two groups: Argatroban (N=144, censored=81) and Historical Control (N=46, censored=20). The graph includes a p value of 0.018 and a footnote explaining censoring as absence of clinical endpoints during follow-up up to 37 days.*

FDA Label Image

Argatroban Structural Formula (Image 06)

Chemical structure of argatroban, the active ingredient in Argatroban injection solution 250 mg/2.5 mL by Mylan Institutional LLC. The diagram shows the molecular formula with atoms and bonds representing the argatroban molecule.*

* 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.