SPL Set ID: 8444da17-6c31-492b-8842-93740f083d9d

1 drug(s) with this SPL Set ID

Open DailyMed details

Bosentan BOSENTAN
62.5 mg Tablet
ZYDUS PHARMACEUTICALS USA INC. FDA Rx Only

Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula: Bosentan has a molecular weight of 569.64 and a molecular formula of C 27 H 29 N 5 O 6 S•H 2 O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan. Bosentan tablets

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