Dabigatran Etexilate Capsule
Product Images NDC 62332-635

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 62332-635). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic 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

Dabigatran-figure1.jpg (Dabigatran Figure1)

A forest plot comparing major bleeding events between Dabigatran Etexilate and Warfarin across various patient subgroups. The chart shows patient counts, event rates, hazard ratios, and 95% confidence intervals illustrating relative safety outcomes for Dabigatran Etexilate versus Warfarin.*

FDA Label Image

Dabigatran-structure.jpg (Dabigatran Structure)

Chemical structure diagram of Dabigatran Etexilate illustrating its molecular configuration, including functional groups and side chains. The structure also indicates the compound as the methanesulfonate salt (CH3SO3H).*

FDA Label Image

Dabigatran-figure2.jpg (Dabigatran Figure2)

A line chart 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 includes four curves representing different creatinine clearance (CrCl) ranges with corresponding aPTT values over time, indicating varied Dabigatran Etexilate doses for patients with CrCl above and below 30 mL/min.*

FDA Label Image

Dabigatran-fig3-1.jpg (Dabigatran Fig3 1)

A forest plot chart displaying pharmacokinetic (PK) fold changes with 90% confidence intervals for various interacting drugs affecting Dabigatran Etexilate. The chart compares AUC and Cmax changes relative to a reference, listing P-gp inhibitors and inducers such as Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin with different dosing schedules.*

FDA Label Image

Dabigatran-fig3-2.jpg (Dabigatran Fig3 2)

A chart showing the fold change and 90% confidence interval in pharmacokinetic parameters (AUC and Cmax) of Dabigatran Etexilate when taken with various interacting drugs. The x-axis represents the change relative to reference from 0.5 to 2. Drugs listed on the y-axis include Atorvastatin, Clopidogrel (at multiple doses), Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine, with their respective dosages and timing relative to Dabigatran administration noted.*

FDA Label Image

Dabigatran-fig4.jpg (Dabigatran Fig4)

A line chart showing estimated cumulative probability over time from randomization (months) for three treatments: Dabigatran Etexilate 110 mg twice daily, Dabigatran Etexilate 150 mg twice daily, and Warfarin. The X-axis represents time in months, and the Y-axis shows estimated cumulative probability. The chart includes a table of subjects at risk corresponding to each time point for the three groups.*

FDA Label Image

Dabigatran-fig5.jpg (Dabigatran Fig5)

A forest plot comparing the hazard ratios of Dabigatran Etexilate versus Warfarin for stroke and systemic embolic events (SEE) across various patient subgroups. The horizontal axis shows hazard ratios with a line at 1, indicating equivalence. Each subgroup is represented by a point estimate with confidence intervals for the hazard ratio, measuring relative treatment effect in patient groups defined by factors such as VKA use, age, gender, weight, history of stroke/TIA, diabetes, DHAD2 score, renal function (CrCl), region, and ASA use.*

FDA Label Image

Dabigatran-75mg-caps.jpg (Dabigatran 75mg Caps)

Label for Dabigatran Etexilate Capsules 75 mg by Alembic Pharmaceuticals Inc. The label states that each capsule contains 75 mg dabigatran etexilate and includes storage instructions, dosage information reference, and packaging warnings. It indicates a package size of 60 capsules and includes a barcode and manufacturing details.*

FDA Label Image

Dabigatran-110mg-caps.jpg (Dabigatran 110mg Caps)

Label for Dabigatran Etexilate Capsules 110 mg by Alembic Pharmaceuticals Inc., showing dosage form as oral capsules in a 60-capsule container. The label includes dosage instructions, storage conditions, and a barcode with associated NDC number 62332-635-60. Manufacturer information and child-resistant packaging warnings are also present.*

FDA Label Image

Dabigatran-150mg-caps.jpg (Dabigatran 150mg Caps)

Label for Dabigatran Etexilate Capsules 150 mg by Alembic Pharmaceuticals Inc. The label shows 60 oral capsules per container. It includes storage instructions, dosage note, manufacturer details, barcode, and a warning that capsules should be used within 4 months after opening and are not interchangeable on a mg-to-mg basis with other dabigatran etexilate forms.*

* 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.