Figure 1 (Dabigatran Fig1)
This is not-available.*
Dabigatran Etexilate Capsule
Product Images NDC 59651-975
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 59651-975). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Aurobindo Pharma 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.
Product Images & Figures Index
Package Label-principal Display Panel (110 mg (10 x 6 Capsules Blister Carton))
This is a description of Dabigatran Etexilate Capsules provided by Aurobindo Pharma USA, Inc. Each pack contains 60 capsules in 10 blister cards with 6 capsules each. The capsules contain 110 mg of dabigatran etexilate equivalent to 830 mg of dabigatran efexlate mesylate. The usual dosage instructions and storage conditions are provided in the medication guide included separately with each pack. It is advised to store the capsules at 20°C to 25°C with excursions permitted to 15°C to 30°C. The product is distributed in the USA and manufactured in India. Keep out of reach of children and store in the original package to protect from moisture.*
Package Label-principal Display Panel (150 mg (60 Capsules Bottle))
The text is not readable.*
Package Label-principal Display Panel (150 mg (10 x 6 Capsules Blister Carton))
Figure 2 (Dabigatran Fig2)
This text provides information about the time course of aPTT (Activated Partial Thromboplastin Time) for a patient receiving Dabigatran Etexilate, with different dose recommendations depending on the patient's creatinine clearance rate. A dose of 150 mg BID is advised when the creatinine clearance is above 30 mL/min, and 75 mg BID when it is below that value. Additionally, the chart shows the aPTT levels for different creatinine clearance thresholds, such as above 50 and 80 mL/min. It also refers to the time in hours for the assessment.*
Figure 3 (Dabigatran Fig3)
Figure 3.2 (Dabigatran Fig4)
This text appears to be a list of interacting drugs, doses, and time differences, along with pharmacokinetic parameters such as AUC and Cmax. It seems to also mention fold change and 90% confidence intervals. The text might be used for evaluating drug interactions and their effects on pharmacokinetics.*
Figure 4 (Dabigatran Fig5)
Figure 5 (Dabigatran Fig6)
Package Label-principal Display Panel (75 mg (60 Capsules Bottle))
This text provides details about the medication "Dabigatran Etexilate Capsules" with a concentration of 75mg per capsule. The capsules are non-substitutable with other forms of dabigatran etexilate on a milligram-to-milligram basis. The text instructs to swallow the capsules whole and mentions the importance of using the product within 4 months once opened. The manufacturer is Aurobindo Pharma USA, Inc., and the medication is made in India. The usual dosage information is available in the package insert. Storage instructions recommend storing at 20° to 25°C with excursions permitted between 15° to 30°C. The text also indicates that the medication guides can be accessed online.*
Package Label-principal Display Panel (75 mg (10 x 6 Capsules Blister Carton))
This is a detailed description of Dabigatran Etexilate Capsules containing 75 mg of dabigatran etexilate equivalent to 86.475 mg of dabigatran etexilate mesylate. The capsules are not interchangeable with other forms of dabigatran etexilate on a mg-to-mg basis. Patients are instructed to swallow the capsules whole. Each pack contains 60 capsules arranged in 10 blister cards with 6 capsules each. The recommended storage conditions are between 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). It is advised to store the medication in the original package to protect it from moisture and keep it out of reach of children. The medication guide is provided separately to each patient, with more information available at the manufacturer's website. The product is made in India and the NDC number is 59651-973-61.*
Package Label-principal Display Panel (110 mg (60 Capsules Bottle))
This text provides important information about Dabigatran Etexilate capsules, including dosage instructions, storage guidelines, and contact information for the manufacturer. It emphasizes the necessity to swallow the capsule whole, use the product within 4 months of opening, and clarifies that the capsules are not interchangeable with other forms of dabigatran etexilate on a milligram-to-milligram basis. The text also specifies the content of each capsule, usual dosage recommendations, and details about storage temperature requirements. Furthermore, it includes a reference to the manufacturer's Medication Guides website and indicates the manufacturing location in India.*
Chemical Structure (Dabigatran Str)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
