Tracleer Tablet, For Suspension
Product Images NDC 66215-232

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tracleer (NDC 66215-232). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actelion Pharmaceuticals Us, 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

Figure 1 (Tracleer 01)

A chart depicting the fold-change effects of various interacting drugs on pharmacokinetic parameters Cmax and AUC, along with corresponding clinical recommendations. Interacting drugs include Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol, with recommendations such as contraindication, cholesterol monitoring, and use of additional contraception.*

FDA Label Image

Figure 2 (Tracleer 02)

A horizontal bar chart showing fold-change of bosentan levels (Cmax and AUC) with interacting drugs Cyclosporin A, Lopinavir/ritonavir, and Rifampin. The chart includes drug interaction types and clinical recommendations like contraindication, dose reduction, and weekly AST/ALT monitoring.*

FDA Label Image

Chemical Structure (Tracleer 03)

Chemical structure of bosentan, the active ingredient in Tracleer oral tablets. The structure includes heterocyclic rings and functional groups consistent with the labeled compound.*

FDA Label Image

Figure 3 (Tracleer 04)

A horizontal bar chart showing fold-change of various interacting drugs with Tracleer (bosentan) focusing on Cmax and AUC parameters. The chart lists interacting drugs on the left, corresponding data points with confidence intervals, and recommendations on the right, including contraindications, monitoring cholesterol, no adjustment needed, or use of additional contraception.*

FDA Label Image

Figure 4 (Tracleer 05)

A data table showing drug interaction effects on bosentan exposure. It lists interacting drugs (Cyclosporin A, Lopinavir/ritonavir, Rifampin, Ketoconazole, Losartan, Sildenafil, Tadalafil), corresponding pharmacokinetic parameters (Cmax, AUC, trough levels), fold-change of bosentan concentration, and dosing recommendations such as contraindicated, dose reduction, AST/ALT monitoring, or no adjustment advised.*

FDA Label Image

Figure 5 (Tracleer 06)

A line graph comparing the distance in meters over time (Baseline, Week 4, Week 8, Week 16) between two groups: Bosentan (n=144) and Placebo (n=69). The Bosentan group shows increasing distance up to Week 8 and then plateauing, while the Placebo group peaks at Week 4 then declines below baseline by Week 16.*

FDA Label Image

Figure 6 (Tracleer 07)

A line graph comparing the percentage of event-free patients over time (in weeks) between Bosentan and placebo groups. The y-axis represents the event-free percentage, and the x-axis shows time in weeks up to 28. The Bosentan group shows higher event-free rates at 89%, while the placebo group shows 63%, with p-values indicated at 16 and 24 weeks.*

FDA Label Image

Figure (Tracleer 08)

An illustration showing a horizontal rectangular box with arrows curving downward on both ends, pointing outward. The image appears to depict a flow or directional process, but does not contain text or specific product details.*

FDA Label Image

Principal Display Panel (62.5 mg Tablet Bottle Carton)

Label for Tracleer (bosentan) tablets 62.5 mg, film-coated oral tablets. The label shows a 60-count package manufactured by Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company. It includes dosing instructions, storage conditions, medication guide reminder, and a barcode. The label highlights the strength, proprietary and generic names, and manufacturer details.*

FDA Label Image

Principal Display Panel (125 mg Tablet Bottle Carton)

Tracleer 125 mg film-coated tablets packaging label. The box contains 60 tablets of bosentan, manufactured by Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company. The label includes storage instructions, dosage directions, and emphasizes dispensing with the enclosed medication guide.*

FDA Label Image

Principal Display Panel (32 mg Tablet Blister Pack Carton)

Tracleer (Bosentan) 32 mg Tablets for Oral Suspension carton label displaying dosage strength and active ingredient. The label includes storage instructions, phenylketonurics warning, quantity details of 56 tablets per carton, and manufacturer information for Actelion Pharmaceuticals US, Inc. Packaging shows barcodes and a note to dispense with an enclosed Medication Guide.*

FDA Label Image

Tracleer 12

Tracleer (bosentan) 32 mg tablets for oral suspension carton label. The green and white label states the active ingredient bosentan and the strength of 32 mg per tablet. It includes usage instructions, storage conditions, and warnings such as dispensing with an enclosed Medication Guide and keeping out of reach of children. The label shows the manufacturer as Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company, and notes the product is made in Switzerland. A barcode and NDC 66215-232-56 are visible.*

* 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.