Argatroban Injection
Product Images NDC 0143-9559

9 FDA label images from Hikma Pharmaceuticals Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 0143-9559). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Arg Chem Structure (Argatroban Injection 1)

Arg Chem Structure (Argatroban Injection 1)
Chemical structure diagram of Argatroban, showing the molecular arrangement of its atoms and bonds as depicted in the image.*
FDA Label Image

Figure 1 (Argatroban Injection 2)

Figure 1 (Argatroban Injection 2)
A graph depicting plasma argatroban concentration (mcg/mL) versus infusion dose (mcg/kg/min), with two correlated measurements: aPTT (seconds ± sem, left y-axis) and ACT (seconds ± sem, right y-axis). The plot shows increases in aPTT and ACT with increasing infusion doses up to 10 mcg/kg/min.*
FDA Label Image

Figure 2 (Argatroban Injection 3)

Figure 2 (Argatroban Injection 3)
A scatter plot comparing INR Warfarin alone (x-axis) versus INR Warfarin plus Argatroban (y-axis) in data from 24 subjects. Two linear trend lines represent Thromboplastin A (ISI 0.88) and Thromboplastin B (ISI 1.78). The chart includes equations for both lines and a note on prediction error associated with Warfarin INR.*
FDA Label Image

Figure 3 (Argatroban Injection 4)

Figure 3 (Argatroban Injection 4)
A survival curve chart depicting the proportion of event-free subjects over 35 study days. It compares Argatroban treatment (160 subjects) versus historical control (147 subjects), with the graph showing censored data points and a p-value of 0.007 indicating statistical significance.*
FDA Label Image

Figure 4 (Argatroban Injection 5)

Figure 4 (Argatroban Injection 5)
A survival curve comparing the proportion event-free over study days between Argatroban treatment (N=144) and historical control (N=46), with statistical significance indicated by a p value of 0.018.*
FDA Label Image

2.5 mL Individual Carton Argatroban (Argatroban Injection 6)

2.5 mL Individual Carton Argatroban (Argatroban Injection 6)
Packaging label for Argatroban Injection, 250 mg/2.5 mL (100 mg/mL) intravenous injection. The label indicates single-use vial, discarding unused portion, and specifies dilution prior to administration. Manufactured by Eclaro Pharma Sciences and distributed by West-Ward Pharmaceuticals Corp. Storage and usage instructions are included, emphasizing protection from light and controlled room temperature storage. The label displays the NDC number and the West-Ward logo.*
FDA Label Image

Argatroban 50 mL Vial Container Label (Argatroban Injection 7)

Argatroban 50 mL Vial Container Label (Argatroban Injection 7)
Argatroban Injection 50 mg/50 mL intravenous infusion vial label by Hikma Pharmaceuticals USA Inc. The label includes dosage form and strength, storage instructions, adult dosage see package insert, and warnings such as do not dilute prior to administration and discard unused portion. It also lists inactive ingredients and manufacturing and distribution information.*
FDA Label Image

50 mL Individual Carton (Argatroban Injection 8)

50 mL Individual Carton (Argatroban Injection 8)
Packaging label for Argatroban Injection 50 mg/50 mL (1 mg/mL) intravenous injection by Hikma Pharmaceuticals USA Inc., distributed by West-Ward Pharmaceuticals. The label indicates a 50 mL single-dose vial, not to be diluted before administration, for intravenous infusion only. Storage instructions and key ingredients are listed, including argatroban, propylene glycol, dehydrated alcohol, and sodium chloride in water for injection. The label includes barcodes, manufacturer and distributor information, and handling warnings.*
FDA Label Image

Argatroban Injection 9

Argatroban Injection 9
A product label for Argatroban injection manufactured by Hikma Pharmaceuticals USA Inc. The label includes a lot number (LOT ABCDE12345), an expiration date placeholder (EXP MMYYYY), a GTIN barcode and number, and a serial number (SN). Dosage and volume specifics are not visible in the image.*

* 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.