Dabigatran Etexilate Capsule, Coated Pellets
Product Images NDC 0904-7254

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 0904-7254). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Major Pharmaceuticals, 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

Dab-igatran-f1-2 (Dab Igatran F1 2)

A forest plot chart comparing major bleeding events on treatment plus 2 days between Dabigatran 150 mg and Warfarin across various patient subgroups. The chart displays hazard ratios with 95% confidence intervals, including subgroups by VKA use at entry, age, gender, weight, history of stroke/TIA, diabetes status, CHADS2 score, CrCl levels, region, and ASA use at baseline. The horizontal axis ranges from 0.1 to 2, indicating comparative safety between Dabigatran and Warfarin.*

FDA Label Image

Dab-igatran-fi-3-2 (Dab Igatran Fi 3 2)

A pharmacokinetic interaction forest plot chart showing fold change and 90% confidence intervals of AUC and Cmax parameters for Dabigatran Etexilate when co-administered with various interacting drugs including Atorvastatin 80 mg qd, Clopidogrel in multiple doses, Diclofenac 50 mg SD, Digoxin 0.25 mg qd, Enoxaparin 40 mg qd, Pantoprazole 40 mg bid, and Ranitidine 150 mg qd. The plot compares changes relative to reference values.*

FDA Label Image

Dab-igatran-fi-4-1-2 (Dab Igatran Fi 4 1 2)

A cumulative probability curve chart comparing three treatments: Dabigatran Etexilate 110 mg twice daily, Dabigatran Etexilate 150 mg twice daily, and Warfarin over a 39-month period. The x-axis shows time from randomization in months, and the y-axis shows estimated cumulative probability. The chart includes a risk table indicating the number of subjects at risk for each treatment group at various time points.*

FDA Label Image

Dab-igatran-graph1-2 (Dab Igatran Graph1 2)

A line graph titled 'aPTT Time Course' showing activated partial thromboplastin time (aPTT) in seconds on the Y-axis against time in hours on the X-axis. The graph includes multiple curves representing different creatinine clearance (CrCl) levels and doses of Dabigatran etexilate over 96 hours, illustrating aPTT changes over time for renal function categories with specified dosing.*

FDA Label Image

Dab-igatran-graph4-2 (Dab Igatran Graph4 2)

A chart titled 'Interacting Drug, Time Difference PK' showing fold change and 90% confidence intervals for various interacting drugs including Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin. The x-axis represents change relative to reference on a logarithmic scale from 0.25 to 4.0, with data points for AUC and Cmax under different dosing conditions or time points.*

FDA Label Image

Dab-igatran-str (Dab Igatran Str)

Chemical structure of the active ingredient Dabigatran Etexilate, depicted as a complex molecular diagram with labeled functional groups and bonds as typically shown in pharmaceutical labeling.*

FDA Label Image

Dabigatran-110mg-60cap-cart (Dabigatran 110mg 60cap Cart)

Dabigatran Etexilate 110 mg capsules label by Major Pharmaceuticals. The label is for a unit dose package containing 60 capsules (6 x 10), marked Rx Only. Storage instructions specify 20°C to 25°C with permitted excursions. Manufactured by Alkem Laboratories Ltd., India, and distributed by Major Pharmaceuticals, Indianapolis, IN. NDC 0904-7254-68.*

FDA Label Image

Dabigatran-150mg-20cap-cart (Dabigatran 150mg 20cap Cart)

Dabigatran Etexilate 150 mg capsules coated pellets unit dose packaging by Major Pharmaceuticals. The box contains 20 capsules (2 x 10) with a note that the package is not child resistant. The label includes storage instructions, manufacturer Alkem Laboratories Ltd., and distributor Major Pharmaceuticals with NDC 0904-7255-10.*

FDA Label Image

Dabigatran-75mg-30cap-cart (Dabigatran 75mg 30cap Cart)

Box packaging label for Dabigatran Etexilate 75 mg capsules by Major Pharmaceuticals. The unit dose container holds 30 capsules (3 x 10) with instructions to swallow whole. It includes storage information, a barcode, and states the product is prescription only. The labeler and manufacturer details are also visible.*

* 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.