SPL Set ID: e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd
1 drug(s) with this SPL Set ID
Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban film coated tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.88. The structural formula is: Rivaroxaban, USP is a pure ( S )-enantiomer. It is non-hygroscopic, white to off-white powder. Rivaroxaban, USP is slightly soluble in acetone and polyethylene glycol 400, and practically insoluble in water. Each film-coated tablet contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and poloxamer. Additionally, the film-coating mixture contains ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. FDA approved dissolution test method and specifications differ from USP.