Argatroban Injection
Product Images NDC 65219-429

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 65219-429). 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

Argat-struc-01.jpg (Argat Struc 01)

Chemical structure of Argatroban, an intravenous injection indicated by the product label. The diagram shows the molecular arrangement including functional groups and bonds characteristic to Argatroban.*

FDA Label Image

Argat-fig-02.jpg (Argat Fig 02)

A scatter plot comparing INR Warfarin Alone (W) on the x-axis with INR Warfarin Plus Argatroban (WA) on the y-axis. The plot includes data points from 24 subjects and two regression lines representing different Thromboplastin types (A and B), with associated prediction equations and confidence intervals for Warfarin INR prediction error.*

FDA Label Image

Argat-fig-01.jpg (Argat Fig 01)

A line graph showing the relationship between infusion dose (mcg/kg/min) and two variables: activated partial thromboplastin time (aPTT, seconds) and activated clotting time (ACT, seconds). The x-axis represents infusion dose from 0 to 10 mcg/kg/min, the left y-axis represents aPTT from 0 to 100 seconds, and the right y-axis represents ACT from 0 to 300 seconds. The top x-axis shows plasma Argatroban concentration (mcg/mL) ranging from 0 to 2.0.*

FDA Label Image

Argat-fig-03.jpg (Argat Fig 03)

A line graph labeled Study 1 showing the proportion of event-free patients over study days. The graph compares Argatroban (N=144, censored=81) with a historical control group (N=46, censored=22). The y-axis represents the proportion event-free, and the x-axis represents study days, with a p value of 0.018 shown, indicating a statistical comparison.*

FDA Label Image

Argat-fig-04.jpg (Argat Fig 04)

A survival curve chart comparing the proportion of event-free subjects over a study period of 35 days. The graph shows two lines: one representing Argatroban (N=160) and the other a historical control group (N=147). The Argatroban group maintains a higher event-free proportion, with a p value of 0.007 indicating statistical significance.*

FDA Label Image

Argat-logo-01.jpg (Argat Logo 01)

FDA Label Image

Argat-label-01.jpg (Argat Label 01)

Label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) intravenous injection. The label indicates a single-dose 50 mL vial, with instructions not to dilute prior to administration. It is labeled for prescription use only, manufactured for Fresenius Kabi USA, LLC, Lake Zurich, IL. Ingredients listed include Argatroban and solvents. Storage instructions specify 20° to 25°C (68° to 77°F), protecting from light and not freezing. A barcode and lot/expiration date fields are also present.*

FDA Label Image

Argat-label-02.jpg (Argat Label 02)

Packaging label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) single-dose vial by Fresenius Kabi USA, LLC. Label includes dosage form as intravenous infusion, warnings not to dilute prior to administration, and storage instructions. The label also lists inactive ingredients and features a barcode and NDC 65219-429-50.*

* 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.