Dabigatran Capsule
Product Images NDC 50090-7530

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dabigatran (NDC 50090-7530). 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

Dabigatran-etexilate-figure-1 (Dabigatran Etexilate Figure 1)

Forest plot comparing major bleeding events between Dabigatran 150 mg and Warfarin across various patient subgroups. The chart includes hazard ratios with 95% confidence intervals for factors like age, sex, weight, history of stroke/TIA, diabetes, CHADS2 score, renal function, geographic region, and aspirin use at baseline, illustrating relative safety outcomes in these groups.*

FDA Label Image

Dabigatran-etexilate-figure-2 (Dabigatran Etexilate Figure 2)

A line graph depicting aPTT (activated partial thromboplastin time in seconds) over time (hours) up to 96 hours. It shows different curves representing aPTT responses for Dabigatran doses of 150 mg BID or 75 mg BID adjusted by creatinine clearance (CrCl) rates, with CrCl categories ranging from ≤30 mL/min to >80 mL/min.*

FDA Label Image

Dabigatran-etexilate-figure-3-1 (Dabigatran Etexilate Figure 3 1)

This chart illustrates pharmacokinetic interactions showing fold change and 90% confidence intervals for AUC and Cmax of dabigatran etexilate when co-administered with various P-gp inhibitors and inducers, including dronedarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil, and rifampicin, plotted against change relative to reference on a logarithmic scale.*

FDA Label Image

Dabigatran-etexilate-figure-3-2 (Dabigatran Etexilate Figure 3 2)

A pharmacokinetic chart showing fold change and 90% confidence intervals for various interacting drugs affecting the pharmacokinetics (AUC and Cmax) of a reference drug over different time differences. The horizontal axis represents the change relative to reference, ranging from 0.5 to 2.0. Drugs listed include Atorvastatin, Clopidogrel at multiple doses, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine.*

FDA Label Image

Dabigatran-etexilate-figure-4 (Dabigatran Etexilate Figure 4)

A line chart displaying estimated cumulative probability over time from randomization up to 39 months for three groups: DE 110 mg bid, DE 150 mg bid, and Warfarin. The x-axis represents time in months, and the y-axis shows estimated cumulative probability. Below the chart, the number of subjects at risk is listed for each time point by group.*

FDA Label Image

Dabigatran-etexilate-figure-5 (Dabigatran Etexilate Figure 5)

A forest plot comparing the hazard ratio (HR) and 95% confidence intervals (CI) for Dabigatran 150 mg versus Warfarin across various patient subgroups. The chart includes subgroup categories such as age, gender, weight, medical history, diabetes status, CHADS2 score, CCr levels, region, and ASA use, showing relative efficacy and risk with corresponding numerical and graphical data.*

FDA Label Image

Dabigatran-etexilate-structure (Dabigatran Etexilate Structure)

Chemical structure of the active ingredient dabigatran etexilate, showing the molecular arrangement and chemical bonds of the compound.*

FDA Label Image

Label Image (Lbl500907530)

DABIGATRAN 150 mg capsule label from A-S Medication Solutions, NDC 50090-7530-0. The label states that each capsule contains 150 mg dabigatran etexilate, equivalent to 150 mg dabigatran. Storage instructions note to keep at 77 degrees Fahrenheit. The package contains 60 capsules. Additional details include lot number and directions to see the package insert.*

* 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.