Dabigatran Etexilate Capsule
Product Images NDC 0378-0265

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 0378-0265). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Dabigatran Etexilate Mesylate (Image 01)

Chemical structure of Dabigatran Etexilate, showing its molecular arrangement with aromatic rings, amide groups, and other functional groups characteristic of the active ingredient's formulation.*

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Figure 1. Adjudicated Major Bleeding By Baseline Characteristics Including Hemorrhagic Stroke Treated Patients (Image 02)

A forest plot chart comparing major bleeding events in patients treated with Dabigatran Etexilate 150 mg versus Warfarin. The chart shows hazard ratios and 95% confidence intervals across various subgroups, including age, gender, weight, history of stroke, diabetes status, CHADS2 score, kidney function, and region. The horizontal axis ranges from 0.1 to 2, indicating which treatment is better for bleeding risk.*

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Figure 3.1. Effect Of P-gp Inhibitor Or Inducer (rifampicin) Drugs On Peak And Total Exposure To Dabigatran (cmax And Auc). Shown Are The Geometric Mean Ratios (ratio) And 90% Confidence Interval (90% Ci). The Perpetrator And Dabigatran Etexilate Dose And Dosing Frequency Are Given As Well As The Time Of Perpetrator Dosing In Relation To Dabigatran Etexilate Dose (time Difference) (Image 03)

A chart titled 'Interacting Drug, Time Difference PK' displays fold changes and 90% confidence intervals in pharmacokinetic parameters AUC and Cmax relative to reference when Dabigatran Etexilate is coadministered with various P-gp inhibitors and inducers. The horizontal axis shows change relative to reference on a logarithmic scale from 0.25 to 4.0, with data points clustered for different drugs and dosing regimens including dronedarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil, and rifampicin.*

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Figure 3.2: Effect Of Non-p-gp Inhibitor Or Inducer, Other Drugs, On Peak And Total Exposure To Dabigatran (cmax And Auc). Shown Are The Geometric Mean Ratios (ratio) And 90% Confidence Interval (90% Ci). The Perpetrator And Dabigatran Etexilate Dose And Dosing Frequency Are Given As Well As The Time Of Perpetrator Dosing In Relation To Dabigatran Etexilate Dose (time Difference) (Image 04)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals for drug interactions with Dabigatran Etexilate. The chart compares AUC and Cmax values relative to reference for various interacting drugs including Atorvastatin, Clopidogrel (multiple doses), Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine, plotted along an x-axis labeled 'Change Relative to Reference' ranging from 0.5 to 2.0.*

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Figure 2. Average Time Course For Effects Of Dabigatran On Aptt, Following Approved Dabigatran Etexilate Capsules Dosing Regimens In Adult Patients With Various Degrees Of Renal Impairment (Image 05)

A line graph titled 'aPTT Time Course' depicting activated partial thromboplastin time (aPTT) in seconds on the y-axis over time in hours on the x-axis, up to 96 hours. The graph shows multiple curves representing different creatinine clearance (CrCl) levels for dabigatran etexilate dosing at 150 mg and 75 mg twice daily, illustrating the effect of renal function on aPTT over time.*

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Figure 5. Stroke And Systemic Embolism Hazard Ratios By Baseline Characteristics (Image 06)

A forest plot comparing the hazard ratios (HR) of Dabigatran Etexilate 150 mg versus Warfarin across various subgroups in patients with stroke or systemic embolic events (SEE). The plot displays confidence intervals and HR values for categories including age, gender, weight, history of stroke/TIA, diabetes status, CHADS2 score, creatinine clearance levels, geographic region, and baseline ASA use, illustrating relative effectiveness and risk between the two treatments.*

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Dabigatran Etexilate Capsules 75 mg Bottle Label (Image 07)

Label for Dabigatran Etexilate Capsules, 75 mg strength, by Mylan Pharmaceuticals Inc. The label includes dosage form (capsules), NDC 0378-0265-93, storage instructions to keep at 20° to 25°C and in original packaging to protect from moisture, a warning that the capsules must be used within 4 months after opening, and that they are not substitutable on a mg-to-mg basis with other dosage forms. The package contains 30 capsules.*

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Figure 2. Kaplan-meier Curve Estimate Of Time To First Stroke Or Systemic Embolism (Image 08)

A line graph showing estimated cumulative probability over time across 39 units (likely weeks or months). The graph compares three groups labeled DE 110 mg bid, DE 150 mg bid, and Warfarin, with cumulative probability increasing gradually for each group, as denoted by solid, dashed, and dotted lines respectively. Below the x-axis, the number of subjects at risk is tabulated for each group at multiple time points.*

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Dabigatran Etexilate Capsules 150 mg Bottle Label (Image 09)

Label for Dabigatran Etexilate Capsules 150 mg by Mylan Pharmaceuticals Inc. The label includes the NDC 0378-0266-93, dosage form as capsules, quantity of 30 capsules, and storage instructions to keep the product at 20° to 25°C and in the original package to protect from moisture. The label notes the product is manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV, and made in India. It also provides dosing and dispensing instructions.*

* 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.