Dabigatran Etexilate Capsule
Product Images NDC 31722-621

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 31722-621). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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

Dabigatrancap150mgcontcarton (Dabigatrancap150mgcontcarton)

Packaging label for Dabigatran Etexilate Capsules 150 mg by Camber Pharmaceuticals, Inc. The label shows the product name and strength, the NDC 31722-622-60, and the quantity of 60 capsules. It includes storage instructions, a contact number, and a note to swallow the capsule whole. The label also states that the product must be used within 4 months once opened and includes manufacturer information for Camber Pharmaceuticals, Inc. and Hetero Labs Limited, India.*

FDA Label Image

Dabigatrancap150mgcontlabel (Dabigatrancap150mgcontlabel)

Label for Dabigatran Etexilate Capsules 150 mg by Camber Pharmaceuticals, Inc. The label states the product is a prescription drug with 60 capsules per container. It includes storage instructions, usage directions, contact information, and a barcode. The label also notes the medication guide availability and safety warnings about using the product within 4 months of opening and preserving the safety seal.*

FDA Label Image

Dabigatrancap75mgcontcarton (Dabigatrancap75mgcontcarton)

Dabigatran Etexilate Capsules 75 mg packaging label from Camber Pharmaceuticals, Inc. The label shows the product name, strength (75 mg), and dosage form (capsules). It indicates a 60-capsule count with prescription-only status. Storage instructions and contact information are also included, along with manufacturing details and a barcode.*

FDA Label Image

Dabigatrancap75mgcontlabel (Dabigatrancap75mgcontlabel)

Dabigatran Etexilate 75 mg capsules label from Camber Pharmaceuticals, Inc. The label states each capsule contains 86.48 mg dabigatran etexilate mesylate equivalent to 75 mg dabigatran etexilate. The package contains 60 capsules and includes storage instructions, usage warnings, and contact information. Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ.*

FDA Label Image

Dabigatrancapcamberlogo1 (Dabigatrancapcamberlogo1)

FDA Label Image

Dabigatrancapcamberlogo2 (Dabigatrancapcamberlogo2)

FDA Label Image

Dabigatrancapfig5

A forest plot comparing stroke or systemic embolic events (SEE) rates between Dabigatran Etexilate 150 mg and Warfarin across various patient subgroups. The plot shows hazard ratios (HR) with 95% confidence intervals for subgroups defined by baseline characteristics such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, renal function, region, and more, indicating relative risk outcomes between the two drugs during the study period.*

FDA Label Image

Dabigatrancapfigure1 (Dabigatrancapfigure1)

A forest plot comparing major bleeding events between Dabigatran 150 mg and Warfarin across various patient subgroups. It includes hazard ratios with 95% confidence intervals, showing relative risk of bleeding events for factors such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, renal function (CrCl), region, and ASA use at baseline. The plot visually represents which treatment is favored for each subgroup.*

FDA Label Image

Dabigatrancapfigure2 (Dabigatrancapfigure2)

A line graph titled 'aPTT Time Course' depicting activated partial thromboplastin time (aPTT) in seconds over 96 hours. The graph shows multiple curves representing different creatinine clearance (CrCl) ranges (≤30, >30 to ≤50, >50 to ≤80, and >80 mL/min) with the highest aPTT times for the lowest CrCl group. The legend notes dosing of Dabigatran etexilate capsules: 150 mg BID when CrCl >30 mL/min and 75 mg BID when CrCl ≤30 mL/min.*

FDA Label Image

Dabigatrancapfigure3-1 (Dabigatrancapfigure3 1)

A forest plot chart titled 'Interacting Drug, Time Difference PK' showing fold changes and 90% confidence intervals for pharmacokinetic parameters AUC and Cmax of various P-gp inhibitors and inducers at different doses and times. The horizontal axis represents change relative to reference, ranging from 0.25 to 4.0, comparing drugs like Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin.*

FDA Label Image

Dabigatrancapfigure3-2 (Dabigatrancapfigure3 2)

A chart displaying pharmacokinetic interactions of various drugs with dabigatran etexilate, showing fold changes and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax). The x-axis represents the change relative to reference on a scale from 0.5 to 2.0. Drugs like Atorvastatin, Clopidogrel, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine are listed with dosage regimens and time differences.*

FDA Label Image

Dabigatrancapfigure4 (Dabigatrancapfigure4)

A line graph showing estimated cumulative probability over time from randomization in months for Dabigatran Etexilate 110 mg bid, 150 mg bid, and Warfarin. The graph includes a subjects at risk table below the x-axis detailing subject counts at various time points for each treatment group.*

FDA Label Image

Dabigatranstructure (Dabigatranstructure)

Chemical structure of Dabigatran Etexilate showing its molecular composition and arrangement as represented in the image.*

* 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.