Dabigatran Etexilate Capsule
Product Images NDC 59651-973

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 59651-973). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1 (Dabigatran Fig1)

A forest plot presenting major bleeding events occurring during treatment plus two days, comparing Dabigatran etexilate 150 mg with Warfarin across various patient subgroups. The plot displays hazard ratios with 95% confidence intervals, indicating treatment effects by subgroup including age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, renal function, geographic region, and ASA use at baseline.*

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Package Label-principal Display Panel (110 mg (10 x 6 Capsules Blister Carton))

Dabigatran Etexilate Capsules 110 mg oral capsules packaging label from Aurobindo Pharma Limited. The label indicates 60 capsules are contained in 10 blister cards of 6 capsules each. It includes dosage strength, medication guide instructions, and storage information. The capsules are described as oblong with two colors shown in an illustration on the label.*

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Package Label-principal Display Panel (150 mg (60 Capsules Bottle))

Label for Dabigatran Etexilate Capsules 150 mg, oral capsule dosage form. The label specifies prescription use and dosage strength, dispensation instructions, storage conditions, and a 60-capsule count. It includes manufacturer details, Aurobindo Pharma USA, Inc., and distribution information. Additional text covers usage guidelines and regulatory codes.*

FDA Label Image

Package Label-principal Display Panel (150 mg (10 x 6 Capsules Blister Carton))

Dabigatran Etexilate Capsules 150 mg oral capsules packaging label by Aurobindo Pharma Limited. The label indicates Rx only status, packaging of 60 capsules in 10 blister cards of 6 capsules each, and includes storage instructions. The capsules are shown as two-toned with markings "DAS" and "150." Distributed by Aurobindo Pharma USA, Inc.*

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Figure 2 (Dabigatran Fig2)

aPTT Time Course graph depicting activated partial thromboplastin time (aPTT) in seconds on the vertical axis against time in hours on the horizontal axis for Dabigatran Etexilate. The graph includes lines for different creatinine clearance (CrCl) ranges, showing prolonged aPTT with lower CrCl values. Dosing information is noted for 150 mg BID when CrCl is greater than 30 mL/min and 75 mg BID when CrCl is 30 mL/min or less.*

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Figure 3 (Dabigatran Fig3)

A pharmacokinetic (PK) chart displaying fold change and 90% confidence intervals of area under the curve (AUC) and maximum concentration (Cmax) for Dabigatran Etexilate when co-administered with various interacting drugs, including P-gp inhibitors and inducers. The horizontal axis shows the change relative to reference values on a logarithmic scale from 0.25 to 4.0, with data points represented as circles and triangles.*

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Figure 3.2 (Dabigatran Fig4)

A pharmacokinetic chart showing fold change and 90% confidence intervals for the effect of various interacting drugs on DABIGATRAN ETEXILATE, including Atorvastatin, Clopidogrel at different doses, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine. The chart plots fold change relative to reference values for AUC and Cmax parameters.*

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Figure 4 (Dabigatran Fig5)

A cumulative probability curve chart comparing Dabigatran Etexilate (DE) at 110 mg bid and 150 mg bid doses to Warfarin over a 39-month period post-randomization. The x-axis represents time in months, and the y-axis shows estimated cumulative probability. A table below the x-axis lists the number of subjects at risk for each treatment group at various time points.*

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Figure 5 (Dabigatran Fig6)

A forest plot chart comparing Dabigatran etexilate 150 mg to Warfarin across various patient subgroups in terms of hazard ratios with 95% confidence intervals. The plot includes subgroups by VKA use at entry, age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, creatinine clearance, region, and ASA use, showing treatment effects on stroke/SEE outcomes.*

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Package Label-principal Display Panel (75 mg (60 Capsules Bottle))

Label for Dabigatran Etexilate Capsules 75 mg, displayed as a 60-capsule package by Aurobindo Pharma Limited. The label includes instructions on dosage and storage, a depiction of a beige capsule imprinted with 'DAB 75', and distributor details for Aurobindo Pharma USA with a barcode and NDC 59651-973-60.*

FDA Label Image

Package Label-principal Display Panel (75 mg (10 x 6 Capsules Blister Carton))

Dabigatran Etexilate Capsules 75 mg packaging label from Aurobindo Pharma Limited. The label indicates prescription use, includes storage instructions, quantity of 60 capsules in 10 blister cards of 6 each, and cautions to swallow the capsule whole. Distributed by Aurobindo Pharma USA, Inc., made in India. NDC 59651-973-61 visible.*

FDA Label Image

Package Label-principal Display Panel (110 mg (60 Capsules Bottle))

Label for Dabigatran Etexilate Capsules 110 mg oral capsules by Aurobindo Pharma Limited. The label includes usage instructions, storage conditions, and distribution information from Aurobindo Pharma USA, Inc. It specifies the product contains 60 capsules and highlights the capsule appearance with partial color and imprint details. The label also includes a barcode and packaging coding area.*

FDA Label Image

Chemical Structure (Dabigatran Str)

Chemical structure of dabigatran etexilate, showing its molecular components and bonds, including aromatic rings, amide groups, and ester linkages, along with a methanesulfonic acid (CH3SO3H) component indicated.*

* 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.