Dabigatran Etexilate Capsule, Coated Pellets
Product Images NDC 50090-7657

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 50090-7657). 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-fig1 (Dab Igatran Fig1)

A data table presenting major bleeding events during treatment over 2+ days comparing Dabigatran 150 mg to Warfarin across various patient subgroups, including VKA use at entry, age, gender, weight, history of stroke, diabetes status, CHA2DS2 score, CrCl levels, region, and ASA use. It includes patient counts, event rates per year, and hazard ratios with 95% confidence intervals, visually represented with a central line plot to compare Dabigatran and Warfarin effectiveness.*

FDA Label Image

Dab-igatran-fig2 (Dab Igatran Fig2)

Line graph titled 'aPTT Time Course' showing activated partial thromboplastin time (aPTT) in seconds on the y-axis and time in hours on the x-axis up to 96 hours. The graph illustrates aPTT changes over time for Dabigatran etexilate doses at 150 mg BID when CrCl is greater than 30 mL/min and 75 mg BID when CrCl is 30 mL/min or less, with separate curves for different creatinine clearance (CrCl) ranges.*

FDA Label Image

Dab-igatran-fig3-1 (Dab Igatran Fig3 1)

A forest plot chart illustrating fold change and 90% confidence intervals of pharmacokinetic parameters (AUC and Cmax) for Dabigatran Etexilate interacting drugs, categorized as P-gp inhibitors and inducers. The X-axis shows change relative to reference from 0.25 to 2.0, while multiple drugs at varying dosages and schedules are plotted with associated confidence intervals.*

FDA Label Image

Dab-igatran-fig3-2 (Dab Igatran Fig3 2)

A forest plot chart displaying the fold change and 90% confidence interval in pharmacokinetic parameters (AUC and Cmax) for various interacting drugs relative to a reference. The chart includes atorvastatin, clopidogrel at different doses, diclofenac, digoxin, enoxaparin, pantoprazole, and ranitidine, plotted against fold change values ranging from 0.5 to 2.0.*

FDA Label Image

Dab-igatran-fig4 (Dab Igatran Fig4)

A line graph showing estimated cumulative probability over time in months from randomization, comparing three treatments: DE 110 mg bid, DE 150 mg bid, and Warfarin. The x-axis represents time in months, and the y-axis represents estimated cumulative probability, with data also indicating subjects at risk for each treatment group at various time points.*

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Dab-igatran-fig5 (Dab Igatran Fig5)

A forest plot chart illustrating the hazard ratio (HR) with 95% confidence intervals for Dabigatran 150 mg versus Warfarin across various subgroups. The subgroups include VKA use at entry, age groups, gender, weight, history of stroke or transient ischemic attack, diabetes status, CHADS2 score, creatinine clearance levels, geographic region, and ASA use at baseline. The plot visually compares the treatment effects, showing whether Dabigatran or Warfarin is favored in each subgroup.*

FDA Label Image

Dab-igatran-structure (Dab Igatran Structure)

Chemical structure of Dabigatran Etexilate, showing the molecular connectivity including aromatic rings, nitrogen atoms, and ester functional groups.*

FDA Label Image

Label Image (Lbl500907657)

Dabigatran Etexilate 150 mg capsules label by A-S Medication Solutions. The label lists active ingredient contents, storage instructions (store at 68 to 77 degrees F), package size of 60 capsules, and includes the NDC number 50090-7657. It indicates the product is oral, contains coated pellets, and advises protection from moisture.*

* 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.