Dabigatran Etexilate Capsule
Product Images NDC 46708-635

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 46708-635). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals 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)

60 Capsules (Dabigatran 150 mg)
Each capsule contains 150 mg of dabigatran etexilate, equivalent to 172.95 mg dabigatran etexilate mesylate. The usual dosages can be found in the package insert or dosage information. Store between 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). Remember to keep the container tightly closed and store in the original packaging to protect from moisture. This medication is manufactured by Alembic Pharmaceuticals Limited and should be swallowed whole. Once opened, the product must be used within 4 months. Not available for substitution based on a mg-to-mg basis. This package contains 60 capsules. Keep out of the reach of children. It is a prescription-only medication.*
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Figure 4 (Dabigatran 4 Figure)

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60 Capsules (Dabigatran 75mg)

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

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

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Dabigatran-fig5.jpg (Dabigatran Fig5)

Dabigatran-fig5.jpg (Dabigatran Fig5)
This is a description of a study comparing Dabigatran Etexiate to Warfarin in patients with stroke/SEE, focusing on various subgroups such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, and region. The study includes VKA usage, baseline characteristics, and ASA usage. The text also contains data on HR (Hazard Ratio) calculations and comparisons between Dabigatran Etexiate and Warfarin in an HR (Hazard Ratio) format with confidence intervals.*
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Dabigatran-figure1.jpg (Dabigatran Figure1)

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Dabigatran-figure2.jpg (Dabigatran Figure2)

Dabigatran-figure2.jpg (Dabigatran Figure2)
This text provides information about the aPTT time course measurement with corresponding values, as well as dosage recommendations for Dabigatran Etexilate based on creatinine clearance levels. The dosage is specified as 150 mg twice daily when creatinine clearance is greater than 30 ml/min and 75 mg twice daily when creatinine clearance is between 30-50 ml/min.*
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.