Dabigatran Etexilate Capsule, Coated Pellets
Product Images NDC 50090-7656

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 50090-7656). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by A-s Medication Solutions, 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

Dab-igatran-f1-2 (Dab Igatran F1 2)

A forest plot chart depicting major bleeding events beyond 2 days in patients treated with Dabigatran 150 mg versus Warfarin. The chart compares hazard ratios and 95% confidence intervals across patient subgroups including VKA use, age, gender, weight, stroke/TIA history, diabetes, CHADS2 score, creatinine clearance, region, and ASA use at baseline. The x-axis shows the hazard ratio scale with segments favoring either Dabigatran or Warfarin.*

FDA Label Image

Dab-igatran-fi-3-2 (Dab Igatran Fi 3 2)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals for AUC and Cmax of Dabigatran Etexilate when administered with various interacting drugs over different time intervals. The graph plots change relative to the reference on the x-axis, listing drugs such as Atorvastatin, Clopidogrel (multiple doses), Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine on the y-axis with corresponding PK parameters.*

FDA Label Image

Dab-igatran-fi-4-1-2 (Dab Igatran Fi 4 1 2)

A graph showing the estimated cumulative probability over time (months) from randomization for three groups: DE 110 mg bid, DE 150 mg bid, and Warfarin. It includes a stepwise line plot for each group and a table of subjects at risk across multiple time points ranging from 0 to 39 months.*

FDA Label Image

Dab-igatran-graph1-2 (Dab Igatran Graph1 2)

A line graph titled 'aPTT Time Course' showing the activated partial thromboplastin time (aPTT) in seconds over a 96-hour period. The graph includes multiple curves representing different creatinine clearance (CrCl) levels and their effect on aPTT after administration of Dabigatran etexilate doses. The legend indicates dosing variations of 150 mg twice daily for CrCl > 30 mL/min and 75 mg twice daily for CrCl ≤ 30 mL/min.*

FDA Label Image

Dab-igatran-graph4-2 (Dab Igatran Graph4 2)

A forest plot displaying fold change and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of various P-gp inhibitors and inducers compared to reference. The x-axis shows change relative to reference spanning from 0.25 to 4.0, with multiple drugs and dosages listed on the y-axis. Data points indicate effects of drugs like Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin on pharmacokinetics.*

FDA Label Image

Dab-igatran-str (Dab Igatran Str)

Chemical structure diagram of Dabigatran Etexilate, showing the molecular connectivity including multiple aromatic rings, amide groups, and ester functional groups, along with a methanesulfonic acid (CH3SO3H) component indicated.*

FDA Label Image

Label Image (Lbl500907656)

Dabigatran Etexilate 75 mg capsule label by A-S Medication Solutions. The label includes product NDC 50090-7656-0, batch number, and states each capsule contains 85.48 mg of dabigatran etexilate mesylate, equivalent to 75 mg dabigatran etexilate. Storage instructions specify 68 to 77 degrees Fahrenheit, store in the original package in a dry, cool place. The package contains 60 capsules.*

* 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.