Dabigatran Etexilate Capsule
Product Images NDC 60505-4348

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 60505-4348). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

Product Images & Figures Index

FDA Label Image

110mg-60-bottle-label.jpg (110mg 60 Bottle Label)

110mg-60-bottle-label.jpg (110mg 60 Bottle Label)
This text provides information about dabigatran etexilate capsules, each containing 110 mg of the active ingredient. It instructs to store the capsules at a temperature range of 20°C to 25°C (68°F to 77°F) with excursions allowed between 15°C to 30°C (59°F to 86°F). The capsules should be kept tightly closed in the original packaging to protect from moisture. Dosage information is available in the package insert. The medication must be kept out of reach of children. The manufacturer is Apotex inc. in Toronto, Ontario, Canada, and the capsules are dispensed in a unit-of-use container with an enclosed medication guide. The product must be used within four months after opening, and it is mentioned that dabigatran etexilate capsules are not interchangeable with other dosage forms of dabigatran etexilate on a milligram-to-milligram basis.*
FDA Label Image

110mg-60-carton-label.jpg (110mg 60 Carton Label)

110mg-60-carton-label.jpg (110mg 60 Carton Label)
FDA Label Image

150mg-60-bottle-label.jpg (150mg 60 Bottle Label)

150mg-60-bottle-label.jpg (150mg 60 Bottle Label)
This text provides information about Dabigatran Etexilate Capsules containing 150 mg of dabigatran etexilate mesylate, stored at 20°C to 25°C. It includes dosage instructions, storage guidelines, and manufacturer details. The medication should be kept in the original package to protect from moisture, and the bottle must be tightly closed. The text also highlights the importance of swallowing the capsule whole and using the product within 4 months of opening. Additionally, it advises keeping the medication out of reach of children and emphasizes that these capsules should not be substituted on a milligram-to-milligram basis with other dabigatran dosage forms.*
FDA Label Image

150mg-60-carton-label.jpg (150mg 60 Carton Label)

150mg-60-carton-label.jpg (150mg 60 Carton Label)
FDA Label Image

75mg-60-bottle-label.jpg (75mg 60 Bottle Label)

75mg-60-bottle-label.jpg (75mg 60 Bottle Label)
Each capsule contains 75 mg of dabigatran etexilate, which is equivalent to 86.49 g of dabigatran etexilate mesylate. The recommended storage temperature is between 20°C to 25°C (68°F to 77°F) with excursions allowed from 15°C to 30°C (59°F to 86°F). The medication should be kept in the original package to protect it from moisture. Instructions advise swallowing the capsule whole and using the product within 4 months of opening. This information is for Dabigatran Etexilate Capsules manufactured by Apotex Inc. in Toronto, Canada, for Apotex Corp. in Weston, Florida. The usual dosage should be confirmed by consulting the package insert.*
FDA Label Image

75mg-60-carton-label.jpg (75mg 60 Carton Label)

75mg-60-carton-label.jpg (75mg 60 Carton Label)
FDA Label Image

Dabigatran Etexilate Structure (Dabigatran Structure)

Dabigatran Etexilate Structure (Dabigatran Structure)
FDA Label Image

Figure 1 (Figure 1)

Figure 1 (Figure 1)
FDA Label Image

Figure 2 (Figure 2)

Figure 2 (Figure 2)
Not available*
FDA Label Image

Figure 3.1 (Figure 3 1)

Figure 3.1 (Figure 3 1)
FDA Label Image

Figure 3.2 (Figure 3 2)

Figure 3.2 (Figure 3 2)
FDA Label Image

Figure 4 (Figure 4)

Figure 4 (Figure 4)
FDA Label Image

Figure 5 (Figure 5)

Figure 5 (Figure 5)
This text provides data on a study involving stroke patients who were part of a randomized set during the study period. It includes information on different patient subgroups based on variables such as VKA use at entry, age, gender, weight, history of stroke or TIA, diabetes at baseline, CHADS2 score, renal function, region, and use of dabigatran etexilate. The text also presents comparisons between dabigatran etexilate and warfarin in terms of efficacy and safety profiles based on the given hazard ratios and confidence intervals.*

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