Argatroban Injection, Solution
Product Images NDC 70121-1037

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 70121-1037). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Llc, 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

1 (Argatroban Injection 1)

Chemical structure diagram of Argatroban, showing its molecular components including a carboxylic acid group, amide bonds, and sulfonyl functional group, consistent with the active ingredient Argatroban 100 mg/mL injection solution.*

FDA Label Image

7 (Argatroban Injection 2)

A line chart depicting the relationship between infusion dose (mcg/kg/min) on the horizontal axis and corresponding aPTT (sec ± sem) and ACT (sec ± sem) values on the vertical axes. The chart also shows plasma Argatroban concentration (mcg/mL) on a secondary horizontal axis above.*

FDA Label Image

8 (Argatroban Injection 3)

A scatter plot graph titled 'INR Relationship of Argatroban Plus Warfarin Versus Warfarin Alone'. It shows data from 24 subjects comparing INR values on the x-axis (INR Warfarin Alone) and y-axis (INR Warfarin Plus Argatroban). Two trend lines represent Thromboplastin A and B with different ISI values (0.88 and 1.78). Equations for each line and an error confidence interval of ± 0.4 units for Warfarin INR prediction are included.*

FDA Label Image

9 (Argatroban Injection 4)

A Kaplan-Meier survival curve showing the proportion of event-free patients over a 35-day study period. The graph compares Argatroban treatment (N=160, censored 119) versus a historical control group (N=147, censored 90). The y-axis represents proportion event-free, and the x-axis represents study days. A p-value of 0.007 indicates statistical comparison between the groups.*

FDA Label Image

10 (Argatroban Injection 5)

A Kaplan-Meier survival curve chart showing the proportion of patients event-free over a study period of 37 days. The chart compares Argatroban treatment (N=144) with historical control (N=46). The y-axis represents the proportion event-free, ranging from 0 to 1, and the x-axis shows study days from 0 to 35. The graph indicates a higher event-free proportion with Argatroban versus historical control, with a p value of 0.018. An annotation explains that censored data refer to patients without clinical endpoints (death, amputation, or new thrombosis) during follow-up.*

FDA Label Image

1 (Argatroban Injection 6)

Label for Argatroban Injection 250 mg/2.5 mL (100 mg/mL) intravenous infusion, by Amneal Pharmaceuticals LLC. The label includes dilution and dosage information, storage instructions, and ingredients including argatroban, D-sorbitol, and dehydrated alcohol. It indicates the product is a 2.5 mL single-dose vial made in India, with a warning to dilute prior to use.*

FDA Label Image

2 (Argatroban Injection 7)

Label for Argatroban Injection 250 mg/2.5 mL (100 mg/mL) solution for intravenous infusion, a single-dose vial by Amneal Pharmaceuticals LLC. The label includes dosage strength, storage instructions, dilution warning, manufacturer details, 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.