Dabigatran Etexilate Capsule
Product Images NDC 60505-4348

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 60505-4348). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

110mg-60-bottle-label.jpg (110mg 60 Bottle Label)

Label for Dabigatran Etexilate Capsules 110 mg, oral dosage form by Apotex Corp. The label indicates a bottle containing 60 capsules. Storage instructions recommend keeping at 20°C to 25°C (68°F to 77°F) with allowed excursions from 15°C to 30°C (59°F to 86°F). The label includes a barcode, manufacturer addresses in Toronto, Ontario, Canada, and Weston, Florida, USA, and cautions to use the product within 4 months of opening. The label also states that the capsules are prescription-only and emphasizes the importance of keeping the bottle tightly closed to protect from moisture.*

FDA Label Image

110mg-60-carton-label.jpg (110mg 60 Carton Label)

Packaging label for Dabigatran Etexilate Capsules 110 mg oral dosage form. The label indicates a quantity of 60 capsules (10 x 6 unit-dose blister cards). It is manufactured by Apotex Corp., with manufacturing details including Apotex Inc. Toronto, Ontario, Canada, and Apotex Corp., Weston, Florida. Instructions to swallow whole and a note that the capsules are not substitutable on a mg-to-mg basis with other dabigatran etexilate forms are included. The package is Rx only and child-resistant.*

FDA Label Image

150mg-60-bottle-label.jpg (150mg 60 Bottle Label)

Label for Dabigatran Etexilate Capsules 150 mg, an oral prescription capsule product by Apotex Corp. The label indicates a 60-capsule count, storage instructions, medication guide requirement, and manufacturer details including Apotex Inc. Toronto and Apotex Corp. Weston, Florida.*

FDA Label Image

150mg-60-carton-label.jpg (150mg 60 Carton Label)

Packaging label for Dabigatran Etexilate Capsules 150 mg by Apotex Corp. The label indicates 60 capsules contained in 10 x 6 unit-dose blister cards. It states storage instructions, dosage guidance to refer to the package insert, and includes child-resistant unit-of-use packaging. The manufacturer is Apotex Inc., Toronto, Ontario, Canada.*

FDA Label Image

75mg-60-bottle-label.jpg (75mg 60 Bottle Label)

Label for Dabigatran Etexilate Capsules 75 mg by Apotex Corp. The label indicates a package of 60 capsules with storage instructions from 20°C to 25°C and warnings to keep the bottle tightly closed and out of reach of children. The label includes the NDC 60505-4347-6 and states that the capsules must be swallowed whole and used within 4 months of opening.*

FDA Label Image

75mg-60-carton-label.jpg (75mg 60 Carton Label)

Packaging label for Dabigatran Etexilate Capsules 75 mg, oral capsules by Apotex Corp. The label states a package size of 60 capsules (10 x 6 unit-dose blister cards). It includes storage instructions, dosage form, and manufacturer information with a barcode present. The label also indicates the product is prescription only (Rx Only).*

FDA Label Image

Dabigatran Etexilate Structure (Dabigatran Structure)

Chemical structure diagram of dabigatran etexilate showing its molecular arrangement including multiple aromatic rings and functional groups.*

FDA Label Image

Figure 1 (Figure 1)

A forest plot displaying major bleeding events comparing Dabigatran Etexilate Capsules 150 mg and Warfarin among various patient subgroups. It includes hazard ratios with 95% confidence intervals, patient counts, and event rates per year, assessing factors such as age, gender, weight, history of stroke/TIA, diabetes, CHADS2 score, creatinine clearance, region, and ASA use at baseline.*

FDA Label Image

Figure 2 (Figure 2)

This line graph titled 'aPTT Time Course' shows activated partial thromboplastin time (aPTT) in seconds over 96 hours for dabigatran etexilate capsules dosed at 150 mg or 75 mg twice daily depending on creatinine clearance (CrCl) levels. The graph includes four curves corresponding to CrCl categories: ≤30, >30 and ≤50, >50 and ≤80, and ≥80 mL/min, illustrating how aPTT changes over time after dosing.*

FDA Label Image

Figure 3.1 (Figure 3 1)

A pharmacokinetic chart showing fold change and 90% confidence intervals (CI) for AUC and Cmax of dabigatran etexilate interacting with various drugs over time. The chart categorizes drugs as P-gp inhibitors and inducers, illustrating their impact on dabigatran etexilate exposure relative to a reference baseline, with data points and error bars plotted on a logarithmic scale.*

FDA Label Image

Figure 3.2 (Figure 3 2)

A pharmacokinetic chart titled 'Interacting Drug, Time Difference PK' displaying fold change and 90% confidence intervals for various drugs (Atorvastatin, Clopidogrel at different doses, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, Ranitidine) relative to a reference. The x-axis shows 'Change Relative to Reference' ranging from 0.5 to 2.0, and markers indicate AUC and Cmax values for each drug interaction.*

FDA Label Image

Figure 4 (Figure 4)

A Kaplan-Meier curve showing estimated cumulative probability over time (in months) from randomization, comparing three groups: dabigatran etexilate (DE) 110 mg twice daily, DE 150 mg twice daily, and warfarin. The chart includes a risk table below indicating the number of subjects at risk at various time points for each group.*

FDA Label Image

Figure 5 (Figure 5)

A forest plot chart comparing the risk of stroke/SEE between Dabigatran Etexilate Capsules 150 mg and Warfarin across different patient subgroups. The chart shows hazard ratios (HR) with 95% confidence intervals for groups based on age, gender, weight, diabetes, kidney function (CrCl), region, and other clinical factors, illustrating relative effectiveness and variability between treatments.*

* 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.