Bosentan Tablet, Film Coated
Product Images NDC 47335-039

View Photos of Packaging, Regulatory Labels, and Product Appearance

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)

Spl-bosentan-figure-1 (Spl Bosentan Figure 1)
This appears to be a chart displaying the interaction between various drugs such as Cyclosporine A, Glyburide, Simvastatin, R-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol, with recommendations on whether to use additional contraception or to monitor cholesterol, based on their effect on Cmax and AUC. Some of the drugs are contraindicated for use together.*
FDA Label Image

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

Spl-bosentan-figure-2 (Spl Bosentan Figure 2)
This appears to be a description of drug interactions and their impact on the medication Bosentan. Cyclosporin A inhibits OATP, while Lopinaviriritonavir inhibits OATP and CYP3A. Rifampin, on the other hand, induces CYP3A and CYP2C9 while inhibiting OATP. The text also suggests that the fold-change of Bosentan is affected by these interactions, and the recommendation is to avoid using Bosentan with these drugs or to consider a dose reduction. Additionally, AST/ALT levels should be monitored weekly.*
FDA Label Image

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

Spl-bosentan-figure-3 (Spl Bosentan Figure 3)
This is a list of drug names and their maximum concentration (Cmax) and area under the curve (Auc) values. Some drugs are noted to have CYP enzyme induction. No further information is available.*
FDA Label Image

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

FDA Label Image

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

FDA Label Image

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

Spl-bosentan-figure-6 (Spl Bosentan Figure 6)
This text appears to be presenting numerical data related to the drug Bosentan, but the information given is incomplete, and it is unclear what the numbers represent. Without additional context, it is not possible to generate a useful description.*
FDA Label Image

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

Spl-bosentan-label-1 (Spl Bosentan Label 1)
This is a medication called Bosentan Tablets, which requires a prescription from a pharmacist. It comes with a medication guide that is given separately to each patient. However, the full labeling is available to be accessed.*
FDA Label Image

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

Spl-bosentan-label-2 (Spl Bosentan Label 2)
This is a medication label for Bosentan Tablets with NDC number 47335-039-86. The pharmacist is requested to dispense medication with Medication Guide provided separately to each patient. It is a prescription-only medication. No further information is available.*
FDA Label Image

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

Spl-bosentan-showbox-1 (Spl Bosentan Showbox 1)
This is a description of a medication known as Bosentan Tablets. It is for hospital use only, and the pharmacist is expected to dispense it with a medication guide provided separately to each patient. The usual dosage is indicated in the packaging insert or prescribing information. The medication should be stored at 20° to 25°C (68" to 77). The manufacturer is Sun Pharmaceutical Industries Ltd, with a distribution center located in Cranbury, New Jersey. The NDC number is 47335-038-64, and the prescription is available in tablet form, with 30 tablets, consisting of 10 x 3 Unit-Dose.*
FDA Label Image

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

Spl-bosentan-showbox-2 (Spl Bosentan Showbox 2)
This is a medication called Bosentan Tablets which comes in a package of 30 tablets, each containing anhydrous bosentan 125 mg. The medication guide is provided separately for each patient. The usual dosage and other details are mentioned in the package insert. The medication should be stored in a controlled temperature range between 15° and 30°C. It is important to keep the medication out of reach of children. The medication is distributed by Sun Pharmaceutical Industries, Inc. and manufactured by Sun Pharmaceutical Industries Ltd.*
FDA Label Image

Spl-bosentan-structure (Spl Bosentan Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.