Dabigatran Capsule
Product Images NDC 50090-7531

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dabigatran (NDC 50090-7531). 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)

A forest plot displaying the hazard ratio and 95% confidence intervals for major bleeding events comparing Dabigatran 150 mg versus Warfarin across various patient subgroups. The subgroups include VKA use at entry, age categories, sex, weight, history of stroke/TIA, diabetes status, CHADS2 score, creatinine clearance, geographic region, and ASA use at baseline. The plot shows the effect size and confidence ranges with markers indicating the comparison outcomes for each subgroup.*

FDA Label Image

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

A line graph titled 'aPTT Time Course' showing activated partial thromboplastin time (aPTT in seconds) over time (hours) up to 96 hours. The graph includes multiple curves representing different creatinine clearance (CrCl) ranges with associated dabigatran doses, showing the effect on aPTT levels over time.*

FDA Label Image

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

A chart depicting fold changes and 90% confidence intervals for pharmacokinetic parameters AUC and Cmax of various P-gp inhibitors and inducers interacting with a reference drug. The x-axis shows the change relative to reference on a logarithmic scale from 0.25 to 4.0, with plotted points representing different dosing regimens and time differences for drugs such as Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin.*

FDA Label Image

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

A chart titled 'Interacting Drug, Time Difference' illustrating pharmacokinetic (PK) fold change and 90% confidence intervals for various drugs relative to a reference. The x-axis represents 'Change Relative to Reference' on a scale from 0.5 to 2.0. The y-axis lists several interacting drugs with their dosages and timing, alongside PK parameters (AUC and Cmax). Data points indicate fold changes and confidence intervals for each combination.*

FDA Label Image

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

A line graph depicting estimated cumulative probability over time from randomization (in months) for three treatment groups: DE 110 mg bid, DE 150 mg bid, and Warfarin. The graph includes a time axis from 0 to 39 months and cumulative probability ranging from 0.00 to 0.05, with risk subject counts displayed below the x-axis for each group at various time points.*

FDA Label Image

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

A forest plot comparing Dabigatran 150 mg versus Warfarin across various patient subgroups (including age, gender, weight, history of stroke/TIA, diabetes status, CHA2DS2 score, creatinine clearance levels, and geographic regions). The plot shows hazard ratios with 95% confidence intervals, indicating the relative risk of outcomes for each subgroup, with Dabigatran generally favored over Warfarin.*

FDA Label Image

Dabigatran-etexilate-structure (Dabigatran Etexilate Structure)

Chemical structure of Dabigatran etexilate, showing its molecular configuration including aromatic rings, nitrogen and oxygen atoms, and side chains, as labeled in the image.*

FDA Label Image

Label Image (Lbl500907531)

Label for DABIGATRAN ETEXILATE 75 mg oral capsules by A-S Medication Solutions. The label states each capsule contains 86.48 mg dabigatran etexilate mesylate equivalent to 75 mg dabigatran etexilate. Package contains 60 capsules. Storage instructions specify to store at 77 degrees Fahrenheit. Includes product NDC 50090-7531-0 and distributor information for A-S Medication Solutions in Libertyville, IL.*

* 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.