Dabigatran Etexilate Capsule
Product Images NDC 72865-272

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 72865-272). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, 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

150-60 (150 60)

Label for Dabigatran Etexilate Capsules 150 mg by XLCare Pharmaceuticals, Inc. The label shows the NDC 72865-273-60 and indicates a package containing 60 capsules. It includes storage instructions, dosage advice to see the package insert, and warnings to keep the bottle tightly closed and out of reach of children. Manufacturing details for Ascent Pharmaceuticals, Inc. and XLCare Pharmaceuticals, Inc. are included.*

FDA Label Image

2.4 (2.4)

Text panel titled 'Pediatric patients with renal impairment' providing specific drug administration or considerations information related to this patient group.*

FDA Label Image

2.7 (2.7)

This text panel contains dosing instructions for Dabigatran Etexilate capsules, advising adult patients transitioning from a parenteral anticoagulant on timing of the initial Dabigatran dose relative to the prior anticoagulant administration or discontinuation.*

FDA Label Image

75-60 (75 60)

Dabigatran Etexilate 75 mg capsules label from XLCare Pharmaceuticals, Inc. The label notes that each capsule contains 86.48 mg dabigatran etexilate mesylate equivalent to 75 mg dabigatran etexilate. The package contains 60 capsules and includes storage and usage instructions. The label also provides manufacturer details and cautionary information.*

FDA Label Image

Figure3.1 (Figure3.1)

A chart illustrating fold changes and 90% confidence intervals for pharmacokinetic interactions of Dabigatran Etexilate with various P-gp inhibitors and inducers. The graph plots AUC and Cmax values comparing time differences and drug combinations relative to a reference, highlighting impact on drug exposure levels.*

FDA Label Image

Figure3.2 (Figure3.2)

A pharmacokinetic chart depicting fold changes and 90% confidence intervals for AUC and Cmax parameters relative to reference values. The chart compares multiple interacting drugs, listed on the left, including Atorvastatin, Clopidogrel at various doses, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine, with plotted points and horizontal error bars illustrating variability in drug concentration changes over time.*

FDA Label Image

Mg1 (Mg1)

A text panel providing information about Dabigatran Etexilate, detailing its use to reduce the risk of stroke and blood clots in adults with atrial fibrillation, and its role in treating and preventing blood clots in the veins of the legs and lungs after prior injectable treatment.*

FDA Label Image

Figure1 (Figure1)

A forest plot chart comparing major bleeding events in patients treated with Dabigatran Etexilate 150 mg versus Warfarin, showing subgroup data by age, gender, weight, stroke history, diabetes, CHADS2 score, renal function, geographic region, and ASA use. The chart displays hazard ratios and 95% confidence intervals for each subgroup, indicating relative bleeding risks between the two treatments.*

FDA Label Image

Figure2 (Figure2)

A line graph titled 'aPTT Time Course' showing activated partial thromboplastin time (aPTT) in seconds on the y-axis versus time in hours on the x-axis over 96 hours. The graph compares aPTT changes with different creatinine clearance (CrCl) levels in patients taking dabigatran etexilate capsules at doses of 150 mg BID when CrCl is above 30 mL/min and 75 mg BID when CrCl is 30 mL/min or below. Four curves represent CrCl ≤ 30, >30 and ≤ 50, >50 and ≤ 80, and >80 mL/min, showing higher aPTT at lower CrCl values.*

FDA Label Image

Figure4 (Figure4)

A line graph depicting estimated cumulative probability over time from randomization in months for three groups: DE 110 mg bid, DE 150 mg bid, and Warfarin. The x-axis represents time in months (0-39), and the y-axis shows cumulative probability (0.00 to 0.05). The graph includes a table of subjects at risk corresponding to each time point for each group.*

FDA Label Image

Figure5 (Figure5)

A forest plot chart comparing the hazard ratios (HR) and 95% confidence intervals for stroke/SEE between Dabigatran 150 mg and Warfarin across various subgroups including age, gender, weight, medical history, diabetes status, CHADS2 and CrCl scores, region, and ASA use. The horizontal axis ranges from 0.1 to 2, indicating the relative effectiveness with notes showing 'Dabigatran Better' on the left and 'Warfarin Better' on the right.*

FDA Label Image

Structural (Structural)

Chemical structure diagram of Dabigatran Etexilate, showing its molecular formula with labeled functional groups and atoms.*

* 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.