Argatroban Injection
Product Images NDC 83301-0500

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Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 83301-0500). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mullan Pharmaceutical 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

Chemical Structure (Argatroban 01)

FDA Label Image

Figure 1 (Argatroban 02)

FDA Label Image

Figure 2 (Argatroban 03)

Figure 2 (Argatroban 03)
This is a data table showing information related to the prediction of Warfarin INR with and without the addition of Argatroban. The data includes error values associated with the prediction of INR for both cases. The study involves 24 subjects and provides insights into the impact of these treatments on thromboplastin levels. This data can be useful for understanding the efficacy of combining Warfarin with Argatroban in managing INR levels in patients.*
FDA Label Image

Figure 3 (Argatroban 04)

Figure 3 (Argatroban 04)
This text provides data on the proportion of event-free individuals in Study 1, comparing Argatroban treatment group (N=160, censored = 119%) with a Historical Control group (N=147, censored = 90%). The p-value for this comparison is 0.007.*
FDA Label Image

Figure 4 (Argatroban 05)

Figure 4 (Argatroban 05)
The text provides details about an evaluation of the proportion of event-free outcomes in Study 1. It includes information on the number of participants in the study, the number censored, and the p-value obtained from the analysis. Additionally, there are numerical values indicating the event-free proportions at different time points in the study.*
FDA Label Image

Principal Display Panel (50 mL Vial Carton)

Principal Display Panel (50 mL Vial Carton)
This is a detailed description of Argatroban Injection, a medication used for intravenous infusion only. The medication comes in a 50mL single-dose vial and each mL contains 1mg of Argatroban along with Propylene Glycol, Dehydrated Alcohol, and Sodium Chloride. It is important to note that the solution should not be diluted prior to administration, and any unused portion should be discarded. The medication does not contain preservatives, and it should not be used if the solution is cloudy or contains a precipitate. The usual adult dosage can be found in the package insert. It is recommended to store the medication at 20° to 25°C and protect it from light by retaining it in the carton. The manufacturing details indicate that it is Manufactured for Mullan Pharmaceutical Inc. in Pasadena, CA and Manufactured by Gland Pharma Limited in Hyderabad, India.*
FDA Label Image

Novaplus Logo (Argatroban 07)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.