Dabigatran Capsule
Product Images NDC 72205-203

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dabigatran (NDC 72205-203). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novadoz Pharmaceuticals 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

Dabigatran-etexilate-cntr-label-150mg (Dabigatran Etexilate Cntr Label 150mg)

Label for Dabigatran Etexilate Capsules 150 mg oral capsules by Novadoz Pharmaceuticals LLC. The label states a package size of 60 capsules and includes storage instructions, dosage guidance, and manufacturer details for MSN Laboratories Private Limited, India. It also features a barcode and cautions to dispense with a patient Medication Guide.*

FDA Label Image

Dabigatran-etexilate-cntr-label-75mg (Dabigatran Etexilate Cntr Label 75mg)

Dabigatran Etexilate Capsules 75 mg oral capsules label showing 60 capsules per bottle. The label includes Rx only designation, NDC 72205-202-60, and drug information including the active ingredient amount per capsule. The labeler is Novadoz Pharmaceuticals LLC, with manufacturing by MSN Laboratories Private Limited, India. Storage instructions and pharmacist dispensing information are also visible.*

FDA Label Image

Dabigatran-etexilate-crtn-label-150mg (Dabigatran Etexilate Crtn Label 150mg)

Dabigatran Etexilate Capsules 150 mg carton label for 60 capsules, labeled as Rx only. The label includes storage instructions, dosage form as capsules, and administration route oral. Manufactured by MSN Laboratories Private Limited, India, and distributed by Novadoz Pharmaceuticals LLC. The label highlights that each capsule contains dabigatran etexilate mesylate equivalent to 150 mg dabigatran etexilate.*

FDA Label Image

Dabigatran-etexilate-crtn-label-75mg (Dabigatran Etexilate Crtn Label 75mg)

Box label for Dabigatran Etexilate Capsules 75 mg by Novadoz Pharmaceuticals LLC. The label specifies 60 capsules per unit and includes storage instructions and pharmacist dispensing guidance, along with manufacturer information for MSN Laboratories Private Limited, India. The label emphasizes swallowing the capsule whole and usage within 4 months after opening.*

FDA Label Image

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

A forest plot comparing major bleeding event rates between Dabigatran 150 mg and Warfarin across various patient subgroups, including age, sex, weight, medical history, and geographic region. The plot presents hazard ratios with 95% confidence intervals, showing relative bleeding risk between the two treatments.*

FDA Label Image

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

A line graph titled 'aPTT Time Course' illustrating activated partial thromboplastin time (aPTT) in seconds over 96 hours. It compares aPTT profiles for dabigatran doses of 150 mg BID for creatinine clearance (CrCl) > 30 mL/min and 75 mg BID for CrCl ≤ 30 mL/min, with various CrCl ranges depicted as different curves showing how aPTT changes over time.*

FDA Label Image

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

A chart presenting fold change and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of various interacting drugs affecting Dabigatran etexilate. The graph compares changes relative to reference values across several Pg-p inhibitors and inducers at different doses and timing, illustrating their impact on Dabigatran drug levels.*

FDA Label Image

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

A pharmacokinetic chart depicting the fold change and 90% confidence intervals for the drugs Atorvastatin, Clopidogrel (various doses), Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine when interacting with another drug. The x-axis represents the change relative to reference in terms of AUC and Cmax, illustrating differences in exposure levels with error bars.*

FDA Label Image

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

A line graph showing the estimated cumulative probability over time from randomization for three treatment groups: Dabigatran Etexilate 110 mg twice daily, Dabigatran Etexilate 150 mg twice daily, and Warfarin. The x-axis represents time in months, while the y-axis shows the cumulative probability. A table below the graph lists the number of subjects at risk at various time points for each group.*

FDA Label Image

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

A forest plot comparing Dabigatran 150 mg versus Warfarin across various patient subgroups, including study population, age, gender, weight, stroke/TIA history, diabetes, CHADS2 score, creatinine clearance, and region. The plot displays hazard ratios with 95% confidence intervals illustrating relative risk between Dabigatran and Warfarin. The horizontal axis measures the hazard ratio, indicating whether Dabigatran or Warfarin is favored.*

FDA Label Image

Dabigatran-etexilate-structure (Dabigatran Etexilate Structure)

Chemical structure of dabigatran etexilate, the active ingredient in the oral capsule medication DABIGATRAN by Novadoz Pharmaceuticals LLC.*

* 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.