Dabigatran Etexilate Capsule, Coated Pellets
Product Images NDC 67877-624

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 67877-624). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascend Laboratories, Llc, 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 150 mg

Label for Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories, LLC. The label indicates the product contains 150 mg dabigatran etexilate per capsule, with directions to swallow whole and instructions for storage and usage. The package contains 60 capsules and includes manufacturer information for Alkem Laboratories, Ltd., India, and barcode details.*

FDA Label Image

Dab Igatran 75 mg

Label for Dabigatran Etexilate Capsules 75 mg by Ascend Laboratories, LLC. It includes dosage form as coated pellets in oral capsules, with a package size of 60 capsules. The label specifies storage instructions, usage warnings, and manufacturer details from Alkem Laboratories, India. The product has an NDC of 67877-474-60.*

FDA Label Image

Dab Igatran Fig1

A forest plot comparing major bleeding event rates between Dabigatran 150 mg and Warfarin across various subgroups, including age, gender, weight, medical history, and region. The chart shows hazard ratios with confidence intervals to indicate relative risk, with the x-axis scaled from 0.1 to 2, marking where Dabigatran or Warfarin may be better.*

FDA Label Image

Dab Igatran Fig2

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 with Dabigatran etexilate dosing at 150 mg BID for CrCl >30 mL/min and 75 mg BID for CrCl ≤30 mL/min. Each curve depicts aPTT values decreasing over 96 hours.*

FDA Label Image

Dab Igatran Fig3 1

A forest plot chart showing fold change and 90% confidence intervals for pharmacokinetic (PK) interactions of various drugs on AUC and Cmax parameters. The chart includes P-gp inhibitors and inducers like Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin, with fold change values relative to a reference line set at 1.0 on the X-axis.*

FDA Label Image

Dab Igatran Fig3 2

A forest plot chart illustrating the pharmacokinetic fold change and 90% confidence intervals for various interacting drugs including Atorvastatin, Clopidogrel at different doses, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine, relative to a reference. The x-axis represents the change relative to reference from 0.5 to 2.0. The y-axis lists the interacting drugs and time differences, with AUC and Cmax pharmacokinetic parameters plotted.*

FDA Label Image

Dab Igatran Fig4

A line graph showing the estimated cumulative probability over time in months from randomization, comparing Dabigatran Etexilate 110 mg twice daily, Dabigatran Etexilate 150 mg twice daily, and Warfarin. The graph includes a risk table indicating the number of subjects at risk for each treatment group at different time points up to 39 months.*

FDA Label Image

Dab Igatran Fig5

A forest plot comparing the hazard ratios (HR) and 95% confidence intervals (CI) of Dabigatran 150 mg versus Warfarin across multiple subgroups, including VKA use at entry, age, gender, weight, history of stroke/TIA, diabetes at baseline, CHADS2 score, creatinine clearance (CrCl), region, and ASA use at baseline. The plot displays the number of patients, event rates per year, and HR values for each subgroup, visually indicating whether Dabigatran or Warfarin is more effective.*

FDA Label Image

Dab Igatran Structure

Chemical structure diagram of dabigatran etexilate, showing its molecular components and arrangement, accompanied by a methanesulfonic acid (CH3SO3H) molecule.*

* 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.