Argatroban Injection
Product Images NDC 65145-126

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 65145-126). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Caplin Steriles 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-injection-1 (Argatroban Injection 1)

Chemical structure of Argatroban, the active ingredient in ARGATROBAN injection. The diagram shows the molecular formula including functional groups and structural bonds characteristic of Argatroban.*

FDA Label Image

Argatroban-injection-2 (Argatroban Injection 2)

A line graph showing the relationship between infusion dose (mcg/kg/min) and plasma argatroban concentration (mcg/mL) along with two measured effects: activated partial thromboplastin time (aPTT, seconds ± sem) and activated clotting time (ACT, seconds ± sem). The graph illustrates dose-dependent responses for aPTT and ACT in relation to plasma argatroban levels.*

FDA Label Image

Argatroban-injection-3 (Argatroban Injection 3)

A scatter plot comparing International Normalized Ratios (INR) of Warfarin alone versus Warfarin plus Argatroban in 24 subjects. Two regression lines represent different thromboplastins (A and B) with respective International Sensitivity Index (ISI) values, showing the relationship and prediction errors between the INR measures.*

FDA Label Image

Argatroban-injection-4 (Argatroban Injection 4)

A survival curve chart comparing the proportion of event-free patients over study days between Argatroban treatment (N=160) and a historical control group (N=147). The graph shows a statistically significant difference with a p value of 0.007.*

FDA Label Image

Argatroban-injection-5 (Argatroban Injection 5)

A Kaplan-Meier curve showing the proportion of event-free patients over study days for Argatroban versus a historical control. The graph compares event-free survival between Argatroban-treated subjects (N=144) and historical controls (N=46), with a p value of 0.018 indicating statistical comparison.*

FDA Label Image

Argatroban-vial (Container Label)

Label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) intravenous injection, single-dose vial. The label includes dosage warnings, ingredients per mL, storage instructions (20° to 25°C, protect from light, do not freeze), and distributor information for Caplin Steriles USA Inc, Hamilton, NJ. The product is made in India by Caplin Steriles Limited.*

FDA Label Image

Argatroban-carton (Carton Label)

Label for Argatroban Injection, USP 50 mg/50 mL (1 mg/mL) intravenous injection by Caplin Steriles Limited. The label indicates it is for single-dose 50 mL vials, with storage instructions to store at 20-25°C, do not freeze, and retain in carton to protect from light. It states that each mL contains 1 mg Argatroban with additional excipients and no preservatives. Distributed by Caplin Steriles USA Inc, made in India, the label includes the NDC 65145-126-01 and barcode.*

* 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.