Dabigatran Etexilate Capsule
Product Images NDC 72603-239

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 72603-239). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, 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

Dabigartanbottlecarton60s (Dabigartanbottlecarton60s)

Dabigatran Etexilate Capsules 150 mg oral capsules packaging label from NorthStar Rx LLC. The label includes 60 capsules per container with NDC 72603-239-01. It states the active ingredient strength, storage instructions, and usage warnings. Manufactured by Hetero Labs Limited, India, with a barcode and medication guide information.*

FDA Label Image

Dabigartanbottlelabel60s (Dabigartanbottlelabel60s)

Label for Dabigatran Etexilate Capsules 150 mg by NorthStar Rx LLC, showing a 60-capsule unit dose container. The label includes dosage strength, storage instructions, safety warnings, manufacturer information for Hetero Labs Limited, and a barcode. It notes the product is prescription only and includes medication guide information.*

FDA Label Image

Dabigartanfigure1 (Dabigartanfigure1)

A forest plot comparing major bleeding events between Dabigatran 150 mg and Warfarin across various patient subgroups. The plot includes hazard ratios with 95% confidence intervals, showing subgroup categories such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, renal function (CrCL), region, and ASA use at baseline. The horizontal axis quantifies relative risk from 0.1 to 2, indicating whether Dabigatran or Warfarin is favored in each subgroup.*

FDA Label Image

Dabigartanfigure2 (Dabigartanfigure2)

A line graph titled 'aPTT Time Course' illustrating activated partial thromboplastin time (aPTT) in seconds versus time in hours over 96 hours. Four curves represent different creatinine clearance (CrCl) ranges: ≤30 mL/min, >30 and ≤50 mL/min, >50 and ≤80 mL/min, and >80 mL/min, showing decreasing aPTT values over time. The graph includes dosing information for Dabigatran etexilate capsules at 150 mg BID for CrCl >30 mL/min and 75 mg BID for CrCl ≤30 mL/min.*

FDA Label Image

Dabigartanfigure31 (Dabigartanfigure31)

A pharmacokinetic interaction chart showing fold changes and 90% confidence intervals for the area under the curve (AUC) and maximum concentration (Cmax) of Dabigatran Etexilate when coadministered with various interacting drugs. The horizontal axis represents change relative to reference on a logarithmic scale from 0.25 to 4. The listed interacting drugs include P-gp inhibitors (droneadarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil) and a P-gp inducer (rifampicin), with time differences noted. Black circles and white triangles represent different parameters or time points for AUC and Cmax values respectively.*

FDA Label Image

Dabigartanfigure32 (Dabigartanfigure32)

A scatter plot graph showing fold change and 90% confidence intervals (CI) for various interacting drugs on pharmacokinetic measures AUC and Cmax relative to a reference. The graph compares drugs such as Atorvastatin, Clopidogrel, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine, illustrating their impact on these pharmacokinetic parameters with confidence intervals around fold change values ranging roughly from 0.5 to 2.0.*

FDA Label Image

Dabigartanfigure4 (Dabigartanfigure4)

A line graph showing estimated cumulative probability over time (in months) comparing Dabigatran Etexilate (DE) 110 mg twice daily, DE 150 mg twice daily, and Warfarin. The x-axis represents time from randomization up to 39 months, and the y-axis shows estimated cumulative probability up to 0.05. A table below the graph lists the number of subjects at risk for each treatment group at various time points.*

FDA Label Image

Dabigartanfigure5 (Dabigartanfigure5)

A forest plot showing stroke and systemic embolic event (SEE) hazard ratios comparing Dabigatran Etexilate 150 mg versus Warfarin across various patient subgroups defined by factors such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, creatinine clearance, region, and baseline aspirin use. The plot presents hazard ratios with 95% confidence intervals, indicating relative risk benefit or harm between Dabigatran and Warfarin.*

FDA Label Image

Dabigartanstructure (Dabigartanstructure)

Chemical structure of dabigatran etexilate, the active ingredient in the medication Dabigatran Etexilate 150 mg capsules by NorthStar RxLLC. The structure includes key functional groups and the methanesulfonic acid moiety (CH3SO3H).*

* 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.