Bosentan Tablet, For Suspension
Product Images NDC 68180-340

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Bosentan (NDC 68180-340). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin 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

Bosentan-carton (Bosentan 32mg 4x14 Unit Dose)

Bosentan-carton (Bosentan 32mg 4x14 Unit Dose)
Packaging label for Bosentan Tablets for Oral Suspension, 32 mg strength, by Lupin Pharmaceuticals, Inc. The label states the product contains phenylalanine 1.85 mg per tablet for oral suspension, is prescription only, and comes in a package of 56 tablets (4 x 14 unit-dose). It includes storage instructions and manufacturer information for Natco Pharma Limited, India, with distribution by Lupin Pharmaceuticals, Naples, FL.*
FDA Label Image

Chemical-structure (Chemical Structure)

Chemical-structure (Chemical Structure)
Chemical structure of Bosentan, showing its molecular configuration with various aromatic rings, sulfonamide group, and functional groups including hydroxyl and methoxy substituents.*
FDA Label Image

Figure 1 (Figure 1)

Figure 1 (Figure 1)
A chart showing drug interaction data for Bosentan with other drugs including Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol. It displays fold-change values for Cmax and AUC of interacting drugs along with recommendations such as contraindicated, monitor cholesterol, or use additional contraception.*
FDA Label Image

Figure 2 (Figure 2)

Figure 2 (Figure 2)
A chart depicting the fold-change of bosentan concentration when coadministered with interacting drugs: Cyclosporin A, Lopinavir/ritonavir, and Rifampin. The graph shows pharmacokinetic parameters such as Cmax, AUC, and trough levels on the x-axis with corresponding recommendations for dose adjustment or monitoring on the right.*
FDA Label Image

Figure-3 (Figure 3)

Figure-3 (Figure 3)
A data table showing interactions between Bosentan and various drugs, listing the interacting drug, pharmacokinetic parameters (Cmax, AUC, plasma concentrations), and corresponding clinical recommendations ranging from contraindications to no adjustment and additional contraception use. The table includes fold-change graphs for each drug interaction parameter.*
FDA Label Image

Figure-4 (Figure 4)

Figure-4 (Figure 4)
A forest plot chart showing the fold-change of bosentan pharmacokinetics when coadministered with various interacting drugs, including Cyclosporin A, Lopinavir/ritonavir, Rifampin, Ketoconazole, Losartan, Sildenafil, and Tadalafil. The chart presents Cmax and AUC changes with corresponding recommendations such as contraindications, dose adjustments, or monitoring guidelines.*
FDA Label Image

Figure-5 (Figure 5)

Figure-5 (Figure 5)
A line chart comparing the walking distance in meters over time between Bosentan and placebo groups. The x-axis indicates time points: Baseline, Week 4, Week 8, and Week 16. The y-axis measures distance in meters. Data show increasing distance for Bosentan over time, peaking around Week 8, while placebo remains low or decreases. Error bars depict variability at each time point.*
FDA Label Image

Figure-6 (Figure 6)

Figure-6 (Figure 6)
A Kaplan-Meier survival curve comparing the percentage of event-free patients over 28 weeks between Bosentan and placebo groups. The x-axis shows time in weeks, and the y-axis represents the event-free percentage. The Bosentan group maintains a higher event-free rate (89%) compared to placebo (63%) at the study endpoint.*
FDA Label Image

Figure-1 (Split Tablet Images)

* 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.