Bosentan Tablet, Film Coated
Product Images NDC 47335-039

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Bosentan (NDC 47335-039). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

Spl-bosentan-figure-1 (Spl Bosentan Figure 1)

A data table showing drug interaction effects for Bosentan with various interacting drugs including Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol. The table lists pharmacokinetic parameters Cmax and AUC, fold-change values of interacting drugs, and corresponding interaction recommendations such as contraindications, monitoring cholesterol, or use of additional contraception.*

FDA Label Image

Spl-bosentan-figure-2 (Spl Bosentan Figure 2)

A chart showing the fold-change effects of interacting drugs on bosentan levels, including Cyclosporin A, Lopinavir/ritonavir, and Rifampin. The chart includes measures such as Cmax and AUC, with recommendations like contraindication, dose reduction, and weekly liver function monitoring (AST/ALT) based on interactions involving OATP, CYP3A, and CYP2C9 pathways.*

FDA Label Image

Spl-bosentan-figure-3 (Spl Bosentan Figure 3)

A fold-change chart detailing drug interactions with Bosentan, showing changes in pharmacokinetic parameters (Cmax, AUC, plasma concentrations) for various interacting drugs including Cyclosporin A, Glyburide, Simvastatin, Digoxin, Sildenafil, Warfarin (S- and R-), Norethindrone, Ethinyl estradiol, Nimodipine, and Tadalafil, along with recommended clinical adjustments such as contraindications, monitoring cholesterol, no adjustments, or use of additional contraception.*

FDA Label Image

Spl-bosentan-figure-4 (Spl Bosentan Figure 4)

A chart showing the fold-change of bosentan concentration in the presence of interacting drugs. The chart lists drugs such as Cyclosporin A, Lopinavir/ritonavir, Rifampin, Ketoconazole, Losartan, Sildenafil, and Tadalafil with corresponding effects on bosentan’s Cmax and AUC. Recommendations like contraindicated, dose reduction, AST/ALT weekly monitoring, and no adjustment are included for each drug interaction.*

FDA Label Image

Spl-bosentan-figure-5 (Spl Bosentan Figure 5)

Line graph comparing distance in meters over time (Baseline, Week 4, Week 8, Week 16) for Bosentan (n=144) versus Placebo (n=69). The Bosentan group shows an increase in meters up to Week 8 and a slight decline by Week 16, while the Placebo group shows a minimal increase at Week 4 followed by a decline, crossing below baseline by Week 16. Error bars indicate variability at each time point.*

FDA Label Image

Spl-bosentan-figure-6 (Spl Bosentan Figure 6)

A Kaplan-Meier survival curve comparing event-free percentages over time in weeks for Bosentan versus placebo. The solid line represents Bosentan, maintaining higher event-free percentages (89%) up to 28 weeks, while the dotted line shows placebo with lower event-free percentages (63%). p-values at 16 and 28 weeks are shown as 0.0038 and 0.0015, respectively.*

FDA Label Image

Spl-bosentan-label-1 (Spl Bosentan Label 1)

Bosentan Tablets 62.5 mg film-coated oral tablets packaging label from Sun Pharmaceutical Industries, Inc. The label indicates a package of 60 tablets, with a note advising pharmacists to dispense with a medication guide. NDC 47335-038-86 is shown along with a barcode.*

FDA Label Image

Spl-bosentan-label-2 (Spl Bosentan Label 2)

Bosentan Tablets 125 mg film-coated tablets packaging label. The label includes the NDC 47335-039-86, indicates 60 tablets per container, and states the product is Rx only. The labeler is Sun Pharmaceutical Industries, Inc., and it instructs pharmacists to dispense the Medication Guide separately to each patient.*

FDA Label Image

Spl-bosentan-showbox-1 (Spl Bosentan Showbox 1)

Bosentan Tablets 62.5 mg film-coated tablets packaging label for hospital use only by Sun Pharmaceutical Industries, Inc. The carton shows 30 tablets in unit-dose packaging, NDC 47335-038-64. It includes dispensing instructions, storage conditions, and manufacturer and distributor details.*

FDA Label Image

Spl-bosentan-showbox-2 (Spl Bosentan Showbox 2)

Packaging label for Bosentan Tablets 125 mg film-coated tablets, oral use, labeled for hospital use only. The package contains 30 tablets in unit-dose packaging (10 x 3). The label includes instructions to dispense with a medication guide and states prescription-only status. Manufactured by Sun Pharmaceutical Industries, Inc., with an NDC number 47335-039-64.*

FDA Label Image

Spl-bosentan-structure (Spl Bosentan Structure)

Chemical structure of bosentan monohydrate, the active ingredient in Bosentan tablets by Sun Pharmaceutical Industries, Inc.*

* 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.