Argatroban
Product Images NDC 63323-526

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 63323-526). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, 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

Fig1 (Arga Fig1)

A pharmacokinetic curve graph showing the relationship between Argatroban infusion dose (mcg/kg/min) on the x-axis and plasma Argatroban concentration (mcg/mL) on the top x-axis, with activated partial thromboplastin time (aPTT, seconds) on the left y-axis and activated clotting time (ACT, seconds) on the right y-axis. The graph includes mean values with standard error of the mean (SEM) indicated for both aPTT and ACT measurements.*

FDA Label Image

Fig2 (Arga Fig2)

A scatter plot comparing INR Warfarin plus Argatroban (WA) on the vertical axis versus INR Warfarin alone (W) on the horizontal axis. Two regression lines represent Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78). The plot includes equations for W as a function of WA for both thromboplastins, with data points from 24 subjects and an error range of ±0.4 units associated with predicted Warfarin INR.*

FDA Label Image

Figure 3 (Arga Fig3)

A Kaplan-Meier curve showing the proportion of event-free patients over study days comparing Argatroban (N=160) to a historical control group (N=147). The graph highlights higher event-free proportions for Argatroban with a p value of 0.007, indicating statistical significance.*

FDA Label Image

Figure 4 (Arga Fig4)

A Kaplan-Meier survival curve comparing Argatroban (N=144) to a historical control group (N=46) over a 35-day study period. The y-axis shows the proportion event-free, and the x-axis shows study days. The graph indicates a statistically significant difference with a p value of 0.018. Censoring is noted for both groups.*

FDA Label Image

Structure (Arga Struct)

Chemical structure diagram of Argatroban, illustrating its molecular composition with specific atomic groups and bonds.*

FDA Label Image

Box (Box)

Drug facts panel for Argatroban Injection by Fresenius Kabi USA, LLC, showing dosage strength of 250 mg per 2.5 mL (100 mg per mL). The panel includes instructions for intravenous use only, a warning in red to dilute prior to administration, preservative-free status, sterility and nonpyrogenic statements, directions to discard unused portions, individual packaging, and Rx only designation. Single dose vial is noted.*

FDA Label Image

Logo (Fk Logo)

FDA Label Image

Vial (Vial)

The label for Argatroban Injection by Fresenius Kabi USA, LLC indicates a concentration of 250 mg per 2.5 mL (100 mg per mL). It states the product is for intravenous use only, emphasizes dilution prior to administration in red text, and notes the product is preservative free. The label mentions it is a single-dose container, requires a prescription, and instructs to discard any unused portion.*

* 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.