Dabigatran Etexilate Capsule
Product Images NDC 43598-453

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 43598-453). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr.reddys Laboratories 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

Container1 (Container1)

Label for Dabigatran Etexilate Capsules 75 mg by Dr. Reddy's Laboratories Inc. The label includes dosage instructions, storage conditions (20°C to 25°C), a 60-capsule count, and emphasizes use within 4 months after opening. The product is made in India and contains a barcode and distributor details.*

FDA Label Image

Container2 (Container2)

Label for Dabigatran Etexilate Capsules 110 mg by Dr. Reddy's Laboratories Inc. The label states each capsule contains 110 mg dabigatran etexilate, equivalent to 126.83 mg dabigatran etexilate mesylate. It includes usage instructions, storage conditions (20-25°C), package quantity (60 capsules), and distributor information. The label emphasizes swallowing the capsule whole and using the product within 4 months of opening.*

FDA Label Image

Container3 (Container3)

Packaging label for Dabigatran Etexilate Capsules, 150 mg strength by Dr.Reddys Laboratories Inc. The label states the capsule must be swallowed whole and used within 4 months after opening. The package contains 60 capsules. Storage instructions and distributor information in Princeton, NJ, are included. The label also features a barcode and a note that the capsules are not substitutable on a mg-to-mg basis with other dabigatran etexilate dosage forms.*

FDA Label Image

Figure1 (Figure1)

A forest plot chart displaying major bleeding events on treatment plus 2 days comparing Dabigatran Etexilate 150 mg with Warfarin across various patient subgroups. It presents hazard ratios (HR) with 95% confidence intervals (CI) for groups including age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, kidney function (CrCL), region, and ASA use. The x-axis shows a scale from 0.1 to 2, indicating relative bleeding risk, with markers for Dabigatran Etexilate and Warfarin effects.*

FDA Label Image

Figure2 (Figure2)

A line graph titled "aPTT Time Course" showing activated partial thromboplastin time (aPTT) in seconds on the y-axis versus time in hours on the x-axis up to 96 hours. The graph displays four curves representing different creatinine clearance (CrCl) levels (>80 mL/min, >50 and ≤80 mL/min, >30 and ≤50 mL/min, ≤30 mL/min) with corresponding aPTT values decreasing over time. Dosage instructions for Dabigatran Etexilate (150 mg BID for CrCl >30 mL/min, 75 mg BID for CrCl ≤30 mL/min) are noted.*

FDA Label Image

Figure3a (Figure3a)

A chart depicting the fold change and 90% confidence intervals for pharmacokinetic parameters AUC and Cmax of dabigatran etexilate when co-administered with various P-gp inhibitors and inducers. The x-axis shows change relative to reference, illustrating how different interacting drugs affect dabigatran etexilate exposure over time differences.*

FDA Label Image

Figure3b (Figure3b)

A scatter plot chart illustrating the pharmacokinetic interactions of various drugs with Dabigatran etexilate, showing fold change and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) relative to reference. The x-axis represents change relative to reference (0.5 to 2.0), and the y-axis lists interacting drugs with dosages and time differences.*

FDA Label Image

Figure4 (Figure4)

A Kaplan-Meier cumulative probability plot showing estimated cumulative probability over time in months from randomization. The graph compares three treatment groups: Dabigatran etexilate 110 mg twice daily (dashed line), Dabigatran etexilate 150 mg twice daily (dotted line), and Warfarin (solid line). Below the graph is a table showing the number of subjects at risk at each time point for the three groups.*

FDA Label Image

Figure5 (Figure5)

A forest plot comparing the efficacy of Dabigatran etexilate 150 mg to Warfarin in various patient subgroups for stroke and systemic embolic events during the study period. The plot shows hazard ratios with 95% confidence intervals for different age groups, gender, weight categories, history of stroke/TIA, diabetes presence, CHADS2 score levels, creatinine clearance ranges, geographical regions (USA, OUS), and ASA use, illustrating relative treatment effects between Dabigatran etexilate and Warfarin.*

FDA Label Image

Structure (Structure)

Chemical structure diagram of the active ingredient Dabigatran etexilate, showing its molecular framework with labeled functional groups and atoms.*

* 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.