Dabigatran Etexilate Capsule
Product Images NDC 46708-636

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 46708-636). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals Limited, 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

60 Capsules (Dabigatran 150 mg)

Dabigatran Etexilate Capsules 150 mg oral capsules label by Alembic Pharmaceuticals Limited. The label includes dosage strength, NDC 46708-636-60, storage instructions, a barcode, and a 60-capsule count. It advises to swallow whole, keep the bottle tightly closed, and use within four months after opening.*

FDA Label Image

Figure 4 (Dabigatran 4 Figure)

A cumulative probability line graph comparing three treatment groups: Dabigatran Etexilate (DE) 110 mg twice daily, DE 150 mg twice daily, and Warfarin. The x-axis represents time from randomization in months, and the y-axis shows the estimated cumulative probability. The chart also includes a table of subjects at risk for each group over time intervals.*

FDA Label Image

60 Capsules (Dabigatran 75mg)

Dabigatran Etexilate Capsules 75 mg packaging label showing the product name, strength, dosage form as capsules, and a package size of 60 capsules. The label includes storage instructions, manufacturer Alembic Pharmaceuticals Limited, and a note to dispense in the original container with the enclosed medication guide.*

FDA Label Image

Dabigatran-fig3-1.jpg (Dabigatran Fig3 1)

A forest plot chart showing fold changes and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of dabigatran etexilate when coadministered with various P-gp inhibitors and inducers, including dronedarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil, and rifampicin. The x-axis represents change relative to reference on a logarithmic scale from 0.25 to 4.*

FDA Label Image

Dabigatran-fig3-2.jpg (Dabigatran Fig3 2)

A scatter plot chart depicting the fold change and 90% confidence interval of pharmacokinetic parameters (AUC and Cmax) for Dabigatran Etexilate with various interacting drugs over different time differences. The horizontal axis represents the change relative to reference values, ranging from 0.5 to 2. The chart details interacting drugs including Atorvastatin, Clopidogrel (at multiple dosages), Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine with respective pharmacokinetic changes.*

FDA Label Image

Dabigatran-fig5.jpg (Dabigatran Fig5)

A forest plot comparing the hazard ratios (HR) and 95% confidence intervals (CI) of Dabigatran Etexilate versus Warfarin for various patient subgroups. The chart displays subgroup categories such as age, gender, weight, history of stroke/TIA, diabetes, and region, plotting HR values with Dabigatran Etexilate favoring left and Warfarin favoring right. The plot includes numerical data on patient counts and event rates for each treatment group.*

FDA Label Image

Dabigatran-figure1.jpg (Dabigatran Figure1)

A forest plot chart comparing major bleeding events between Dabigatran Etexilate and Warfarin treatment groups across various patient subgroups. The x-axis represents the hazard ratio with a scale from 0.1 to over 2.0, indicating relative risk. The chart displays subgroup categories like VKA use, age, gender, weight, history of stroke/TIA, diabetes status, CHADS2 score, creatinine clearance, region, and ASA use at baseline, showing number of patients, events, and hazard ratios with confidence intervals for each.*

FDA Label Image

Dabigatran-figure2.jpg (Dabigatran Figure2)

A line graph labeled 'aPTT Time Course' showing activated partial thromboplastin time (aPTT) in seconds on the y-axis versus time in hours on the x-axis up to 96 hours. Four curves represent different creatinine clearance (CrCl) ranges, illustrating the aPTT response at different renal functions with Dabigatran Etexilate doses noted as 150 mg BID for CrCl > 30 mL/min and 75 mg BID for CrCl ≤ 30 mL/min.*

FDA Label Image

Dabigatran-structure.jpg (Dabigatran Structure)

Chemical structure of Dabigatran Etexilate, displaying its molecular components and arrangement as represented in the diagram.*

* 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.