Argatroban Injection
Product Images NDC 0143-9288

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 0143-9288). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Arg Chem Structure (Argatroban Injection Premierprorx 1)

Chemical structure of Argatroban, the active ingredient in the intravenous injection drug Argatroban by Hikma Pharmaceuticals USA Inc.*

FDA Label Image

Figure 1 (Argatroban Injection Premierprorx 2)

A line graph depicting the relationship between infusion dose (mcg/kg/min) on the x-axis and two variables on the y-axes: activated partial thromboplastin time (aPTT, seconds ± SEM) on the left and activated clotting time (ACT, seconds ± SEM) on the right. A secondary x-axis shows plasma argatroban concentration (mcg/mL). Curves indicate the increases in aPTT and ACT with higher infusion doses of Argatroban.*

FDA Label Image

Figure 2 (Argatroban Injection Premierprorx 3)

A scatter plot comparing INR Warfarin plus Argatroban (WA) on the Y-axis against INR Warfarin alone (W) on the X-axis. The graph includes data points from 24 subjects and two regression lines representing Thromboplastin A and Thromboplastin B, each with different ISI values (0.88 and 1.78 respectively). Equations for the regression lines and an error confidence interval of ±0.4 units are shown on the graph.*

FDA Label Image

Figure 3 (Argatroban Injection Premierprorx 4)

A line chart comparing the proportion of event-free subjects over 35 study days between Argatroban (N=160) and a Historical Control group (N=147). The y-axis shows proportion event-free from 0 to 1, and the x-axis shows study days from 0 to 35. A p value of 0.007 is indicated.*

FDA Label Image

Figure 4 (Argatroban Injection Premierprorx 5)

A line chart comparing the proportion of event-free cases over 35 study days between Argatroban-treated patients (N=144, censored=81) and a historical control group (N=46, censored=20). The Argatroban group shows a higher event-free proportion. The graph includes a p value of 0.018 indicating statistical comparison.*

FDA Label Image

7.5.17 Version Container (Argatroban Injection Premierprorx 6)

Argatroban Injection 250 mg/2.5 mL (100 mg/mL) intravenous injection vial. The label includes storage instructions to keep the vial at 20° to 25°C (68° to 77°F) in its original carton, avoid freezing, and notes to dilute prior to administration. Labeler is Hikma Pharmaceuticals USA Inc., distributed by West-Ward Pharmaceuticals Corp.*

FDA Label Image

Carton Resized (Argatroban Injection Premierprorx 7)

Packaging label for Argatroban Injection 250 mg/2.5 mL (100 mg/mL) intravenous injection. Label shows it is a single-use vial portion, manufactured by Exela Pharma Sciences, LLC, and distributed by West-Ward Pharmaceuticals Corp. It includes storage instructions and notes the absence of preservatives. The label features the PremierProRx brand and instructs dilution prior to administration.*

FDA Label Image

Argatroban Injection Premierprorx 8

Label panel showing a lot number, expiration date, GS1 GTIN barcode, and serial number for Argatroban injection 250 mg/2.5 mL by Hikma Pharmaceuticals USA Inc. The lot number is ABCDE12345 and expiration date is in month/year format (MMYYYY). The GTIN and serial number appear as numeric codes beneath the barcode.*

* 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.