Pradaxa Capsule
Product Images NDC 0597-0108

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Pradaxa (NDC 0597-0108). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Boehringer Ingelheim Pharmaceuticals Inc., 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

Pradaxa 01

A forest plot comparing major bleeding events between Pradaxa 150 mg and Warfarin, showing hazard ratios and 95% confidence intervals across various patient subgroups such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, creatinine clearance, region, and ASA use. The plot visualizes relative safety outcomes for these groups.*

FDA Label Image

Pradaxa 02

Chemical structure diagram of dabigatran etexilate mesylate, the active ingredient in Pradaxa capsules. The diagram shows the molecular structure with labeled atoms, highlighting key functional groups and the mesylate salt form (CH3SO3H).*

FDA Label Image

Pradaxa 03

A line chart titled "aPTT Time Course" showing activated partial thromboplastin time (aPTT) in seconds on the y-axis over 96 hours on the x-axis. The graph includes four curves representing different creatinine clearance (CrCl) levels: ≤30 mL/min, >30 and ≤50 mL/min, >50 and ≤80 mL/min, and >80 mL/min. The chart also has a note on Pradaxa dosing recommending 150 mg BID when CrCl is over 30 mL/min and 75 mg BID when CrCl is 30 mL/min or below.*

FDA Label Image

Pradaxa 04

A scatter plot illustrating fold change and 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of Pradaxa (dabigatran etexilate mesylate) when co-administered with various P-gp inhibitors and inducers. The x-axis represents change relative to reference on a logarithmic scale from 0.25 to 4. The plot compares multiple dosing regimens and time differences for drugs such as dronedarone, ketoconazole, amiodarone, clarithromycin, quinidine, ticagrelor, verapamil, and rifampicin.*

FDA Label Image

Pradaxa 05

A scatter plot showing fold change and 90% confidence intervals for pharmacokinetic parameters AUC and Cmax of dabigatran altered by various interacting drugs over different time differences. The x-axis represents change relative to reference, ranging from 0.5 to 2.0, with a vertical line at 1.0 indicating no change. Interacting drugs listed include Atorvastatin, Clopidogrel (various doses), Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine with corresponding AUC and Cmax data points and confidence intervals shown.*

FDA Label Image

Pradaxa 06

A Kaplan-Meier curve showing estimated cumulative probability over time in months from randomization for three groups: Dabigatran etexilate mesylate 110 mg twice daily, 150 mg twice daily, and Warfarin. The graph plots cumulative event probability with a count of subjects at risk at various time points for each treatment group below the x-axis.*

FDA Label Image

Pradaxa 07

A forest plot comparing stroke/SEE outcomes between Pradaxa 150 mg and Warfarin across various patient subgroups. The plot shows hazard ratios with 95% confidence intervals, indicating relative effectiveness of Pradaxa versus Warfarin in populations defined by factors such as age, gender, weight, history of stroke, diabetes, CHADS2 score, creatinine clearance, region, and ASA use at baseline. The horizontal axis denotes treatment effect favoring either Pradaxa or Warfarin.*

FDA Label Image

Pradaxa 08

FDA Label Image

Pradaxa 09

Pradaxa 110 mg capsules label containing dabigatran etexilate for oral use. The label shows the product name, strength, and dosage form on a white background with blue and orange highlights. It states that the capsules must be swallowed whole and used within 4 months once opened. The label includes storage instructions, distributor information (Boehringer Ingelheim Pharmaceuticals, Inc.), and a barcode.*

FDA Label Image

Pradaxa 10

Pradaxa 75 mg capsules packaging label by Boehringer Ingelheim Pharmaceuticals Inc. Shows 60 capsules in the container. Label states the active ingredient dabigatran etexilate with a capsule image marked R75. Includes storage instructions, dosage note, and legal/manufacturer information, plus a barcode. The label emphasizes use within 4 months after opening and non-substitutability with other dabigatran etexilate dosage forms.*

FDA Label Image

Pradaxa 11

Pradaxa 150 mg capsules label by Boehringer Ingelheim Pharmaceuticals Inc., with NDC 0597-0360-55. The label includes dosage strength, capsule image, storage instructions, dispensing instructions, barcode, and manufacturer details. It indicates 60 capsules per container, with specific usage and substitution warnings.*

* 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.