Dabigatran Etexilate Capsule
Product Images NDC 72603-239

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 72603-239). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, 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

Dabigartanbottlecarton60s (Dabigartanbottlecarton60s)

Dabigartanbottlecarton60s (Dabigartanbottlecarton60s)
This text is about Dabigatran Etexilate Capsules, each containing 150mg of dabigatran etexilate mesylate. The capsules should be swallowed whole and used within 4 months after opening. It warns against using other forms of dabigatran etexilate on a mg-to-mg basis. The medication guide is available online or by phone. It provides dosage information, storage instructions, and safety precautions. The capsules are dispensed in a unit of use container with a medication guide. Each box contains 60 capsules and is manufactured in India.*
FDA Label Image

Dabigartanbottlelabel60s (Dabigartanbottlelabel60s)

Dabigartanbottlelabel60s (Dabigartanbottlelabel60s)
This text provides information on Dabigatran Etexilate capsules in a 150 mg strength. It includes instructions on how to use the medication, storage conditions, dosage information, and contact details for further inquiries. The capsules must be used within 4 months of opening and should be stored in the original package to protect them from moisture. The dosage must be as per the package insert guidelines. The medication is produced by Northstar Rx LLC and manufactured by Hetero Labs Limited in India.*
FDA Label Image

Dabigartanfigure1 (Dabigartanfigure1)

Dabigartanfigure1 (Dabigartanfigure1)
This is information on a medical study evaluating major bleeding events related to the use of Dabigatran 150 compared to Warfarin in a group of patients. The data includes details on patient demographics such as age, gender, medical history, and baseline characteristics. The study also provides hazard ratios with their 95% confidence intervals comparing the safety profile of Dabigatran 150 versus Warfarin in the treatment of patients.*
FDA Label Image

Dabigartanfigure2 (Dabigartanfigure2)

Dabigartanfigure2 (Dabigartanfigure2)
This description provides information on the time course of aPTT (activated partial thromboplastin time) with varying doses of Dabigatran etexilate capsules based on the patient's creatinine clearance (CrCl). The recommended dose is 150 mg twice a day for patients with a CrCl greater than 30 mL/min and 75 mg twice a day for those with a CrCl less than 30 mL/min. The data presented in the chart show aPTT values at specific time points (24, 48, 72 hours) for patients with different CrCl levels.*
FDA Label Image

Dabigartanfigure31 (Dabigartanfigure31)

Dabigartanfigure31 (Dabigartanfigure31)
This text seems to contain a list of different drugs and their dosing schedules in relation to specific times or other drugs. It also mentions interactions, doses, and time differences for pegp Inbibitors and Pegp Indusers. It might be a reference for healthcare professionals to understand how certain drugs interact with each other and affect pharmacokinetics.*
FDA Label Image

Dabigartanfigure32 (Dabigartanfigure32)

Dabigartanfigure32 (Dabigartanfigure32)
This is a list showing the interacting drug along with the time difference, PK fold change, and 90% confidence interval for various medications such as Atorvastatin, Clopidogrel, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine. The table appears to be comparing the AUC and Cmax values for different dosages and formulations of these drugs, with changes relative to a reference point.*
FDA Label Image

Dabigartanfigure4 (Dabigartanfigure4)

Dabigartanfigure4 (Dabigartanfigure4)
This is a medication dosing schedule with time intervals and number of subjects at risk for a clinical trial evaluating the effect of different dosages on subjects. Specifically, the text includes dosages of DE (possibly a medication) at 110mg and 150mg, alongside Warfarin, with time points in months and the number of subjects at risk at each interval. The data seems to involve monitoring the subjects' responses over time.*
FDA Label Image

Dabigartanfigure5 (Dabigartanfigure5)

Dabigartanfigure5 (Dabigartanfigure5)
This text provides data from a study comparing Dabigatran 150 and Warfarin for different patient subgroups based on age, gender, weight, medical history, and other factors. It includes information on the total number of patients in each subgroup, VKA use at entry, age distribution, gender distribution, weight distribution, history of stroke or TIA, diabetes at baseline, CHADS2 score, creatinine clearance rate, region, and ASA use at baseline. Additionally, it presents the number of patients, events, and event rates per year for Dabigatran 150 and Warfarin, as well as hazard ratios with confidence intervals for comparing the efficacy of Dabigatran 150 with Warfarin. The study evaluates the effectiveness of these anticoagulants in stroke prevention.*
FDA Label Image

Dabigartanstructure (Dabigartanstructure)

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