Dabigatran Capsule
Product Images NDC 72205-204

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Dabigatran (NDC 72205-204). 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-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-structure (Dabigatran Etexilate Structure)

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

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.*

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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.*

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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.*

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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-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-blister-carton-75mg (Dabigatran Etexilate Blister Carton 75mg)

Packaging label for Dabigatran Etexilate Capsules 75 mg by Novadoz Pharmaceuticals LLC. The label indicates the capsule dosage form and a package size of 60 capsules (6 x 10 unit-dose). It includes storage instructions, dispensing guidance, and manufacturer and distributor information. NDC 72205-202-34 is visible.*

FDA Label Image

Dabigatran-etexilate-blister-foil-75mg (Dabigatran Etexilate Blister Foil 75mg)

Dabigatran Etexilate 75 mg capsules packaging label showing individual capsule labels arranged in a 2-row by 5-column grid. Each label includes dosage strength, distributor Novadoz Pharmaceuticals LLC, manufacturing origin India, issuance date 10/2024, and a barcode with lot and expiration placeholders.*

FDA Label Image

Dabigatran-etexilate-cntr-label-110mg.jpg (Dabigatran Etexilate Cntr Label 110mg)

Label for Dabigatran Etexilate Capsules 110 mg, a prescription oral capsule product by Novadoz Pharmaceuticals LLC. The label states the NDC as 72205-203-60 and indicates that the product contains 60 capsules. It includes storage instructions, manufacturer information (MSN Laboratories Private Limited, India), and a phone number for Novadoz Pharmaceuticals.*

FDA Label Image

Dabigatran-etexilate-blister-carton-110mg (Dabigatran Etexilate Blister Carton 110mg)

Dabigatran Etexilate Capsules 110 mg packaging label for oral capsules, containing 60 capsules (6 x 10 unit-dose). The label includes dosage instructions, storage conditions, and a pharmacist note to dispense the medication guide. Manufactured by MSN Laboratories Private Limited and distributed by Novadoz Pharmaceuticals LLC. The label displays the NDC 72205-203-34 and includes barcodes and expiration information.*

FDA Label Image

Dabigatran-etexilate-blister-foil-110mg (Dabigatran Etexilate Blister Foil 110mg)

Dabigatran Etexilate Capsule 110 mg label sheet with ten identical labels featuring the proprietary name, strength, dosage form, and distributed by Novadoz Pharmaceuticals LLC. Each label includes the NDC 72205-203-11, barcode, and placeholder for lot and expiry dates. The capsules are made in India and marked Rx only.*

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-blister-carton-150mg (Dabigatran Etexilate Blister Carton 150mg)

Packaging label for Dabigatran Etexilate Capsules 150 mg, oral capsules. The label indicates a package size of 60 capsules (6 x 10 unit-dose). It includes usage instructions such as swallowing the capsule whole and storage conditions. The labeler is Novadoz Pharmaceuticals LLC and the manufacturer is MSN Laboratories Private Limited, India. The label features the NDC 72205-204-34 and notes it is Rx only.*

FDA Label Image

Dabigatran-etexilate-blister-foil-150mg (Dabigatran Etexilate Blister Foil 150mg)

Labels for Dabigatran Etexilate Capsules 150 mg from Novadoz Pharmaceuticals LLC. Each label states the dosage strength, distribution details, manufacturing country (India), and includes a barcode, lot number placeholder, expiration date placeholder, and issuance date (10/2024). The labels are arranged in a grid format with repeated identical content.*

* 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.