Argatroban Injection, Solution
Product Images NDC 68083-568

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 68083-568). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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

Argatroban-spl-fig-1 (Argatroban Spl Fig 1)

A line graph showing the relationship between infusion dose (mcg/kg/min) on the x-axis and two measures on the y-axes: aPTT (sec ± sem) on the left and ACT (sec ± sem) on the right. The graph includes two plotted lines indicating changes in aPTT and ACT corresponding to increasing plasma Argatroban concentration (mcg/mL) shown on a secondary x-axis at the top.*

FDA Label Image

Argatroban-spl-fig-2 (Argatroban Spl Fig 2)

A scatter plot graph showing the relationship between INR Warfarin Alone (W) on the x-axis and INR Warfarin Plus Argatroban (WA) on the y-axis. The plot includes data from 24 subjects and two regression lines labeled Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78). Equations for each line and an error confidence interval of ± 0.4 units associated with Warfarin INR prediction are also displayed.*

FDA Label Image

Argatroban-spl-fig-3 (Argatroban Spl Fig 3)

A line graph titled 'STUDY 1' comparing the proportion event-free over 35 study days between two groups: Argatroban (N=160) and Historical Control (N=147). The y-axis shows proportion event-free from 0 to 1, and the x-axis shows study days from 0 to 35. The Argatroban group maintains a higher event-free proportion compared to the Historical Control group, with a significant p value of 0.007 indicated.*

FDA Label Image

Argatroban-spl-fig-4 (Argatroban Spl Fig 4)

A line graph labeled 'STUDY 1' showing proportion event-free over study days from 0 to 35. Two curves compare Argatroban (N = 144) and Historical Control (N = 46) groups, with respective censoring noted. The Argatroban group shows a higher proportion event-free over time. A p value of 0.018 is indicated.*

FDA Label Image

Argatroban-spl-structure (Argatroban Spl Structure)

Chemical structure of the active ingredient Argatroban, showing its molecular components and arrangement including key functional groups and atoms.*

FDA Label Image

Carton-label (Carton Label)

Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) intravenous infusion solution in a 50 mL single-dose vial by Gland Pharma Limited. Label includes storage instructions, ingredients, usage warnings, and barcode. The product is for intravenous infusion only and should not be diluted prior to administration.*

FDA Label Image

Container-label (Container Label)

Label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) intravenous injection solution. The label includes dosing instructions, storage conditions, and warnings not to dilute prior to administration and to discard unused portions. It is a 50 mL single-dose vial manufactured by Gland Pharma Limited, Hyderabad, India, with a barcode and NDC 68083-568-01.*

* 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.