SPL Set ID: 171272c7-d76e-4352-81bc-fcb40386d7d0

Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion. The structural formula is: Voriconazole USP is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H -1,2,4-triazol-1-yl)-2-butanol with a molecular formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. Voriconazole USP drug substance is a white or almost white powder. Voriconazole for injection is a white lyophilized powder containing nominally 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2) ] . Chemical Structure