Argatroban Solution
Product Images NDC 68083-141

7 FDA label images from Gland Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 68083-141). 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-structure (Argatroban Structure)

Argatroban-structure (Argatroban Structure)
Chemical structure of Argatroban featuring its molecular components including amine groups, sulfonamide, and carboxyl groups, representing the active ingredient Argatroban in the intravenous solution form.*
FDA Label Image

Argatroban-figure1 (Argatroban Figure1)

Argatroban-figure1 (Argatroban Figure1)
A line graph showing the relationship between infusion dose of Argatroban (mcg/kg/min) on the x-axis and corresponding coagulation measures on the y-axes. The left y-axis represents activated partial thromboplastin time (aPTT) in seconds, and the right y-axis represents activated clotting time (ACT) in seconds. The graph displays increasing aPTT and ACT values with higher infusion doses, with data points connected by solid and dashed lines.*
FDA Label Image

Argatroban-figure2 (Argatroban Figure2)

Argatroban-figure2 (Argatroban Figure2)
A scatter plot chart comparing INR Warfarin plus Argatroban (WA) on the y-axis against INR Warfarin alone (W) on the x-axis. Two linear regression lines represent data for Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78). The chart includes data from 24 subjects and indicates error and confidence intervals associated with prediction of Warfarin INR values.*
FDA Label Image

Figure3 (Argatroban Figure3)

Figure3 (Argatroban Figure3)
A Kaplan-Meier survival curve comparing Argatroban and Historical Control groups over 37 study days. The y-axis shows the proportion event-free, and the x-axis represents study days. The graph includes censorship details and a p value of 0.007 indicating statistical analysis of outcomes.*
FDA Label Image

Figure4 (Argatroban Figure4)

Figure4 (Argatroban Figure4)
A Kaplan-Meier survival curve chart showing the proportion of event-free participants over a 37-day study period. The chart compares Argatroban treatment (N=144) to a historical control group (N=46), with censored data indicated. The p-value of 0.018 is noted on the graph.*
FDA Label Image

Argatroban-vial-label (Argatroban Vial Label)

Argatroban-vial-label (Argatroban Vial Label)
Label for Argatroban in 0.9% Sodium Chloride Injection, solution for intravenous infusion. Strength is 125 mg/125 mL (1 mg/mL) in a single-dose vial. Manufactured by Gland Pharma Limited, Hyderabad, India. Label includes storage instructions, dosage note, and caution to protect from light and avoid freezing.*
FDA Label Image

Argatroban-carton-label (Argatroban Carton Label)

Argatroban-carton-label (Argatroban Carton Label)
Packaging label for Argatroban in 0.9% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL) solution for intravenous infusion. The package contains 2 single-dose vials, labeled as ready to use and not to dilute. Manufactured by Gland Pharma Limited. Storage instructions include protecting from light and storing between 20° to 25°C. The label also includes warnings such as keeping out of reach of children and not using if the solution is cloudy or contains precipitate.*

* 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.