Dabigatran Etexilate Capsule
Product Images NDC 50090-8158

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 50090-8158). 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

Dabigartanfigure1 (Dabigartanfigure1)

A forest plot chart comparing major bleeding event hazard ratios between Dabigatran 150 mg and Warfarin across multiple patient subgroups, including age, gender, weight, history of stroke, diabetes, CHADS2 score, renal function (CrCL), region, and aspirin use. The chart visualizes hazard ratios with confidence intervals, indicating relative safety outcomes between the two drugs.*

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Structure (Structure)

Chemical structure of Dabigatran Etexilate, the active ingredient shown in the molecular diagram depicting its atomic bonds and arrangement.*

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Dabigartanfigure2 (Dabigartanfigure2)

Line graph titled 'aPTT Time Course' displaying activated partial thromboplastin time (aPTT) in seconds over 96 hours for dabigatran etexilate capsules. Four curves represent aPTT changes based on creatinine clearance (CrCl) ranges: ≤30, >30 and ≤50, >50 and ≤80, and >80 mL/min. Dosage information notes 150 mg BID for CrCl >30 mL/min and 75 mg BID for CrCl ≤30 mL/min.*

FDA Label Image

Dabigartanfigure31 (Dabigartanfigure31)

A pharmacokinetic chart illustrating the fold change and 90% confidence intervals for various interacting drugs affecting Dabigatran Etexilate. The x-axis represents change relative to reference from 0.25 to 4.0. The y-axis lists P-gp inhibitors and inducers (e.g., Dronedarone, Ketokonazole, Amiodarone, Rifampicin) with associated dosages and timing. Data points show AUC and Cmax values for these drugs alone or with timing differences, indicating their impact on Dabigatran exposure.*

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Dabigartanfigure32 (Dabigartanfigure32)

A forest plot chart depicting the pharmacokinetic fold change and 90% confidence intervals of dabigatran etexilate when coadministered with various interacting drugs, with change relative to reference on the x-axis. It compares AUC and Cmax values for drugs such as atorvastatin, clopidogrel at different doses, diclofenac, digoxin, enoxaparin, pantoprazole, and ranitidine.*

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Dabigartanfigure4 (Dabigartanfigure4)

A line graph depicting the estimated cumulative probability over time (months) from randomization comparing Dabigatran Etexilate 110 mg bid, Dabigatran Etexilate 150 mg bid, and Warfarin. The x-axis represents time in months (0 to 39) and the y-axis represents estimated cumulative probability (0 to 0.05). The graph includes a risk table indicating the number of subjects at risk over time for each treatment group.*

FDA Label Image

Dabigartanfigure5 (Dabigartanfigure5)

A forest plot chart comparing stroke and systemic embolic events (SEE) rates between Dabigatran Etexilate 150 mg and Warfarin across various patient subgroups including age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, creatinine clearance, region, and ASA use. The chart displays hazard ratios with 95% confidence intervals to show the relative risk between the two treatments.*

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Camber-logo (Camber Logo)

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Camber-logo-2 (Camber Logo 2)

FDA Label Image

Label Image (Lbl500908158)

Dabigatran Etexilate 150 mg capsule container label for oral use by A-S Medication Solutions. The label includes product and lot numbers, total active ingredient content per capsule, storage instructions (68 to 77 degrees Fahrenheit), packaging protection advice, and indicates a quantity of 60 capsules. The label also notes the distributor and regulatory compliance details.*

* 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.