Dabigatran Etexilate Capsule
Product Images NDC 62332-635

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 62332-635). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic 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.

FDA Label Image

Dabigatran-150mg-caps.jpg (Dabigatran 150mg Caps)

Dabigatran-150mg-caps.jpg (Dabigatran 150mg Caps)
Each capsule contains 150 mg dabigatran etexilate equivalent to 172.95 g dabigatran etexilate mesylate. The usual dosage information can be found on the package insert. Store between 20°C to 25°C with excursions permitted at 15°C to 30°C. The medication should be kept in the original package to protect from moisture. Manufactured by Alembic Pharmaceuticals Ltd. for Alembic Pharmaceuticals, Inc. This prescription product should be dispensed in the unit container provided with the enclosed medication guide. Swallow the capsule whole and use within 4 months of opening. This package is child resistant. More information can be found in the medication guide available at the provided website.*
FDA Label Image

Figure 4 (Dabigatran 4 Figure)

Figure 4 (Dabigatran 4 Figure)
Estimated cumulative probability of DE 110 mgbid, DE 150 bid mg, and Warfarin over time from randomization [months]. The data shows the subjects at risk and the probabilities at different time points.*
FDA Label Image

Dabigatran-75mg-caps.jpg (Dabigatran 75mg Caps)

FDA Label Image

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

Dabigatran-fig3-1.jpg (Dabigatran Fig3 1)
This is a list of interacting drugs and time differences for administration. The text includes various medications such as Gronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin, among others. It provides specific dosages and timing instructions for each drug. These details are crucial for healthcare professionals to prevent adverse interactions between the listed medications.*
FDA Label Image

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

FDA Label Image

Dabigatran-fig5.jpg (Dabigatran Fig5)

Dabigatran-fig5.jpg (Dabigatran Fig5)
The provided text appears to be a table displaying data from a study comparing Dabigatran Etexiate and Warfarin in stroke patients. It includes information on subgroups of patients, demographic characteristics such as age, gender, weight, comorbidities like diabetes and history of stroke, as well as risk scores, regions, and ASA usage at baseline. The table also seems to list Hazard Ratios with their corresponding 85% confidence intervals for the comparison between Dabigatran Etexiate and Warfarin. The data seems to be segmented based on different criteria.*
FDA Label Image

Dabigatran-figure1.jpg (Dabigatran Figure1)

FDA Label Image

Dabigatran-figure2.jpg (Dabigatran Figure2)

Dabigatran-figure2.jpg (Dabigatran Figure2)
This text appears to mention a time course for aPTT (activated partial thromboplastin time) with different doses of Dabigatran Etexilate based on creatinine clearance levels. A dose of 150 mg twice a day is recommended when the creatinine clearance is greater than 30 mL/min, while a dose of 75 mg twice a day is recommended when creatinine clearance is 30 mL/min or less.*
FDA Label Image

Dabigatran-structure.jpg (Dabigatran Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.