Dabigatran Capsule
Product Images NDC 60687-963

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dabigatran (NDC 60687-963). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by American Health Packaging, 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

Ahp97432

White capsule imprinted with "MD 150" in black, identified as DABIGATRAN 150 mg oral capsule. The image shows both sides of the capsule; the imprint is on one half, the other half is plain. This capsule is a prescription medication labeled by American Health Packaging.*

FDA Label Image

Ahp96321

DABIGATRAN 75 mg oral capsule, white to off-white, oblong-shaped, imprinted with 'MD 75'. The capsule is used as a prescription drug. Labeler: American Health Packaging.*

FDA Label Image

Dabigatran-etexilate-figure-1 (Dabigatran Etexilate Figure 1)

A forest plot chart illustrating major bleeding events comparing Dabigatran 150 mg with Warfarin across various patient subgroups. The chart includes subgroups such as VKA use at entry, age, gender, weight, history of stroke/TIA, diabetes at baseline, CHADS2 score, creatinine clearance levels, region, and ASA use at baseline. Hazard ratios and 95% confidence intervals for each subgroup are shown, indicating relative safety outcomes between the two treatments.*

FDA Label Image

Dabigatran-etexilate-structure (Dabigatran Etexilate Structure)

Chemical structure of dabigatran etexilate, showing its molecular arrangement with distinct aromatic rings, amide groups, and alkyl chains along with a methanesulfonic acid moiety.*

FDA Label Image

Dabigatran-etexilate-figure-2 (Dabigatran Etexilate Figure 2)

A line graph titled 'aPTT Time Course' illustrating activated partial thromboplastin time (aPTT) in seconds over 96 hours. The graph shows multiple curves representing different creatinine clearance (CrCl) rates, comparing Dabigatran doses of 150 mg BID for CrCl >30 mL/min and 75 mg BID for CrCl ≤30 mL/min, with aPTT decreasing over time across varying CrCl categories.*

FDA Label Image

Figure 3.1 (Dabigatran Etexilate Figure 3 1)

A fold change and 90% confidence interval plot showing the pharmacokinetic interactions of various drugs with DABIGATRAN. The chart compares AUC and Cmax values for different doses and dosing schedules of P-gp inhibitors and inducers, including Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin, relative to a reference baseline.*

FDA Label Image

Figure 3.2 (Dabigatran Etexilate Figure 3 2)

A forest plot chart showing fold change and 90% confidence intervals of pharmacokinetic parameters (AUC and Cmax) for various interacting drugs relative to a reference. The interacting drugs include Atorvastatin 80 mg qd, Clopidogrel (300 mg SD, 600 mg SD, 75 mg qd), Diclofenac 50 mg SD, Digoxin 0.25 mg qd, Enoxaparin 40 mg qd, Pantoprazole 40 mg bid, and Ranitidine 150 mg qd. The x-axis represents fold change from 0.5 to 2.0, with markers indicating the magnitude of PK changes.*

FDA Label Image

Dabigatran-etexilate-figure-4 (Dabigatran Etexilate Figure 4)

A Kaplan-Meier plot showing estimated cumulative probability over time from randomization (in months) comparing three treatment groups: DE 110 mg bid, DE 150 mg bid, and Warfarin. The x-axis represents time up to 39 months, and the y-axis shows cumulative probability up to 0.05. The chart includes numbers of subjects at risk for each group at various time points.*

FDA Label Image

Dabigatran-etexilate-figure-5 (Dabigatran Etexilate Figure 5)

A forest plot chart comparing the hazard ratio of Dabigatran 150 mg versus Warfarin in patients across various subgroups, including age, gender, weight, history of stroke/TIA, diabetes, CHA2DS2 score, creatinine clearance, and region. The horizontal axis quantifies the hazard ratio with confidence intervals, showing overall and subgroup-specific treatment effects.*

FDA Label Image

75 mg Dabigatran Etexilate Capsules Carton.jpg (75 mg Dabigatran Etexilate Capsules Carton)

Dabigatran Etexilate capsules, 75 mg strength, oral dosage form. The label indicates a package size of 30 capsules (3 x 10) and is marked Rx only. The label includes usage instructions such as storing conditions and advises dispensing a medication guide. Distributed by American Health Packaging.*

FDA Label Image

75 mg Dabigatran Etexilate Capsule Blister.jpg (75 mg Dabigatran Etexilate Capsule Blister)

Multiple identical labels for Dabigatran Etexilate 75 mg capsules. Each label shows the product name, dosage form as capsule, strength of 75 mg, along with placeholder lot and expiration information. The labeler is American Health Packaging, with barcode and numeric codes included.*

FDA Label Image

150 mg Dabigatran Etexilate Capsules Carton.jpg (150 mg Dabigatran Etexilate Capsules Carton)

Dabigatran Etexilate 150 mg capsules label showing packaging information for 20 capsules (5 x 4) by American Health Packaging. The label includes NDC number 60687-974-32, dosage strength, storage instructions, and pharmacist dispensing guidance. A barcode and QR code for medication guide and prescribing information are also visible.*

FDA Label Image

150 mg Dabigatran Etexilate Capsule Blister.jpg (150 mg Dabigatran Etexilate Capsule Blister)

Four identical labels for Dabigatran Etexilate capsules, each indicating a strength of 150 mg. The labels show the product name, dosage form as capsules, and packaging by American Health Packaging located in Columbus, OH. Each label includes a barcode and placeholders for lot number and expiration date.*

* 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.