Bosentan Tablet, Coated
Product Images NDC 68382-446

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Bosentan (NDC 68382-446). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa 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

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A chart showing the fold-change of interacting drugs with Bosentan, measuring pharmacokinetic parameters Cmax and AUC. Drugs listed include Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol, with recommendations such as contraindicated, monitor cholesterol, and use additional contraception.*

FDA Label Image

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A chart depicting drug interactions with bosentan showing fold-change in bosentan concentration. It lists interacting drugs (Cyclosporin A, Lopinavir/ritonavir, Rifampin) with corresponding pharmacokinetic parameters (Cmax, AUC, Ctrough). Recommendations include contraindication for Cyclosporin A, dose reduction for Lopinavir/ritonavir, and weekly AST/ALT monitoring for Rifampin.*

FDA Label Image

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Chemical structure of Bosentan, including its sulfonamide, pyrimidine, and phenyl groups, along with a hydrate indicated by H2O.*

FDA Label Image

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A table listing drug interactions with Bosentan, showing interacting drugs alongside measurements of Cmax and AUC or plasma concentrations, with graphical fold-change indicators. The table includes recommendations such as 'contraindicated,' 'monitor cholesterol,' 'use additional contraception,' or 'no adjustment' for each interacting drug.*

FDA Label Image

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A chart showing the fold-change of bosentan levels when co-administered with various interacting drugs. The x-axis represents fold-change values on a logarithmic scale. The chart compares Cmax and AUC values for interacting drugs like Cyclosporin A, Lopinavir/ritonavir, Rifampin, Ketoconazole, Losartan, Sildenafil, and Tadalafil, with dose adjustment recommendations such as contraindicated, dose reduction, weekly monitoring, or no adjustment.*

FDA Label Image

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A line graph comparing distance in meters over time (Baseline, Week 4, Week 8, Week 16) between Bosentan (n=144) and placebo (n=69) groups. Bosentan shows increasing and sustained distances while placebo shows a peak at Week 4 followed by decline. Error bars indicate variability at each time point.*

FDA Label Image

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A Kaplan-Meier survival curve chart comparing event-free percentages over time in weeks for Bosentan versus placebo. The graph shows a higher percentage event-free rate for Bosentan, indicated by a solid line, compared to placebo, shown with a dotted line, with significant p-values at indicated time points.*

FDA Label Image

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A table titled 'Acceptable birth control options' listing four options for birth control methods. Each option includes different combinations of methods such as intrauterine devices, hormonal contraceptives, barrier methods with spermicide, sterilization procedures, and male condoms. The table is organized into columns labeled Option 1 through Option 4, detailing specific acceptable methods within each category.*

FDA Label Image

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Bosentan Tablets 62.5 mg film-coated tablets label showing the product name, strength, and dosage form. The label includes a picture of a round tan tablet with imprint "446," NDC 68382-446-01, and states a package size of 100 tablets for oral use. It also lists the manufacturer as Cadila Healthcare Ltd. (India) and distributor as Zydus Pharmaceuticals USA Inc. (New Jersey). Instructions for pharmacists and storage conditions appear on the label.*

FDA Label Image

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Bosentan Tablets 125 mg film-coated oral tablets label shows a light brown, oval tablet imprinted with '447'. The packaging is for 100 tablets, labeled by Zydus Pharmaceuticals USA Inc. It includes dosage information, storage conditions, and manufacturer details (Cadila Healthcare Ltd., India). The NDC is 68382-447-01.*

* 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.