Dabigatran Capsule
Product Images NDC 42291-034

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran (NDC 42291-034). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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 (033 60)

Dabigatran Etexilate Capsules 75 mg oral capsules packaged by AvKARE. The label indicates this unit-of-use container holds 60 capsules, with a pharmacy instruction to dispense it with a medication guide. Storage instructions specify keeping the bottle tightly closed at 25°C (77°F). The label includes cautionary notes about dose usage and capsule stability after opening.*

FDA Label Image

60 (034 60)

The packaging label for Dabigatran Etexilate Capsules, 150 mg, by AvKARE. The label indicates the product is for oral use, prescription only, with 60 capsules per container. It includes storage information, dosing instructions, and a note to dispense with a medication guide. The label also shows manufacturing details and a barcode.*

FDA Label Image

Dabigatran-etexilate-figure-1 (Dabigatran Etexilate Figure 1)

A forest plot showing major bleeding events comparing Dabigatran 150 mg to Warfarin across various patient subgroups. The chart displays hazard ratios with 95% confidence intervals, highlighting subgroups by VKA use at entry, age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, kidney function (CrCL), geographic region, and ASA use. The plot compares relative safety outcomes between treatments.*

FDA Label Image

Dabigatran-etexilate-figure-2 (Dabigatran Etexilate Figure 2)

Line graph titled 'aPTT Time Course' illustrates activated partial thromboplastin time (aPTT) in seconds over 96 hours following Dabigatran dosing. It compares aPTT responses across different creatinine clearance (CrCl) levels, showing dose and CrCl-dependent changes in aPTT over time.*

FDA Label Image

Dabigatran-etexilate-figure-3-1 (Dabigatran Etexilate Figure 3 1)

A pharmacokinetic chart showing fold change and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) of various P-gp inhibitors and inducers interacting with a drug. Data points for multiple drugs including dronedarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil, and rifampicin are plotted relative to a reference value, indicating their impact on drug exposure over time.*

FDA Label Image

Dabigatran-etexilate-figure-3-2 (Dabigatran Etexilate Figure 3 2)

A forest plot chart showing fold changes and 90% confidence intervals for pharmacokinetic parameters AUC and Cmax of dabigatran etexilate when coadministered with various interacting drugs and at different time differences. The x-axis represents change relative to reference, ranging from 0.5 to 2.0. Drugs listed include atorvastatin, clopidogrel (multiple doses), diclofenac, digoxin, enoxaparin, pantoprazole, and ranitidine, each with their respective dosing times.*

FDA Label Image

Dabigatran-etexilate-figure-4 (Dabigatran Etexilate Figure 4)

A Kaplan-Meier plot showing the estimated cumulative probability of an event over time from randomization in days, comparing Dabigatran Etexilate (DE) at 110 mg twice daily and 150 mg twice daily doses to Warfarin. The graph includes a risk table indicating the number of subjects at risk at various time points for each treatment group.*

FDA Label Image

Dabigatran-etexilate-figure-5 (Dabigatran Etexilate Figure 5)

A forest plot comparing the hazard ratios of Dabigatran 150 mg versus Warfarin across various subgroups including patient characteristics (entry status, age, gender, weight), medical history (stroke/TIA, diabetes), CHADS2 score, creatinine clearance levels, and geographic region. The plot visually shows the estimated hazard ratios with 95% confidence intervals, indicating relative risk favoring either Dabigatran or Warfarin.*

FDA Label Image

Dabigatran-etexilate-structure (Dabigatran Etexilate Structure)

Chemical structure diagram of dabigatran etexilate, the active ingredient in DABIGATRAN capsules. The diagram shows the molecular components and bonds, including a methanesulfonic acid (CH3SO3H) group, relevant to the medication's chemical composition.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.