Argatroban Injection
Product Images NDC 16729-430

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 16729-430). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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

Figure 1 (Argatroban Figure 1)

A line graph showing the relationship between infusion dose (mcg/kg/min) and two parameters: aPTT (sec ± sem) on the left y-axis and ACT (sec ± sem) on the right y-axis, plotted against plasma Argatroban concentration (mcg/mL) on the top x-axis. The graph depicts increasing values for aPTT and ACT with higher infusion doses of Argatroban.*

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Figure 2 (Argatroban Figure 2)

A scatter plot graph illustrating the relationship between INR Warfarin Alone (W) on the x-axis and INR Warfarin Plus Argatroban (WA) on the y-axis. Two regression lines represent Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78), based on data from 24 subjects. The graph includes linear equations for each line and notes the error margin associated with warfarin INR prediction.*

FDA Label Image

Figure 3 (Argatroban Figure 3)

A Kaplan-Meier survival curve chart comparing the proportion of event-free patients over a 35-day study period between Argatroban (N=160) and Historical Control (N=147). The y-axis represents proportion event-free, and the x-axis shows the study day. The graph indicates statistical significance with a p value of 0.007. Censoring notes define clinical endpoints such as death, amputation, or new thrombosis during follow-up.*

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Figure 4 (Argatroban Figure 4)

A Kaplan-Meier survival curve chart comparing the proportion of event-free patients over a 37-day study period for Argatroban (N=144) and a historical control group (N=46). The vertical axis shows the proportion event-free, and the horizontal axis shows study days from 0 to 35 with a p-value of 0.018 indicating statistical comparison. Censoring is noted for both groups.*

FDA Label Image

Principal Display Panel (Carton Label)

Packaging label for Argatroban in 0.9% Sodium Chloride Injection, 50 mg/50 mL (1 mg/mL) intravenous injection by Accord Healthcare Inc. The label details dosage form, concentration, and storage instructions. Manufactured by Intas Pharmaceuticals Limited, India, for Accord Healthcare, Inc., Durham, NC. It is a single-dose vial, not to be diluted prior to administration, with no preservative, and includes warnings on storage temperatures and solution clarity.*

FDA Label Image

Principal Display Panel (Carton Label)

Label for Argatroban 1 mg/mL (50 mg/50 mL) in 0.9% Sodium Chloride Injection by Accord Healthcare Inc. The packaging states it is for intravenous infusion only, with 10 single dose vials. The label includes storage instructions, handling precautions, and manufacturer details.*

FDA Label Image

Principal Display Panel (Vial Label)

Label for Argatroban in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg/mL) intravenous infusion solution. It is a single dose vial, labeled for no dilution prior to administration and instructing to discard unused portions. The label includes storage instructions, manufacturer information (Accord Healthcare, Inc. and Intas Pharmaceuticals Limited), and barcodes.*

FDA Label Image

Structural Formula (Argatroban Structural Formula)

Chemical structure of Argatroban showing its molecular configuration with multiple ring systems, functional groups including carboxyl and sulfonamide, and various nitrogen and oxygen atoms.*

* 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.