SPL Set ID: ff09a726-9f9b-4e30-b509-396781293220

ORBACTIV (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug for intravenous infusion. The chemical name for oritavancin is [4"R]-22- O -(3-amino-2,3,6-trideoxy-3- C -methyl-α-L- arabino -hexopyranosyl)- N 3''-[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] vancomycin phosphate [1:2] [salt]. The empirical formula of oritavancin diphosphate is C 86 H 97 N 10 O 26 Cl 3 ∙2H 3 PO 4 and the molecular weight is 1989.09. The chemical structure is represented below: ∙2H 3 PO 4 ORBACTIV for injection is supplied as a sterile white to off-white lyophilized powder in a single-dose clear glass vial that contains 400 mg of oritavancin (equivalent to 444 mg oritavancin diphosphate) and the following inactive ingredients: mannitol (200 mg) and phosphoric acid (to adjust pH 3.1 to 4.3). Each vial is reconstituted with sterile water for injection and further diluted with 5% dextrose injection (D5W) for intravenous infusion. Both the reconstituted solution and the diluted solution for infusion should be a clear, colorless to pale yellow solution, free of visible particles [see Dosage and Administration (2.3) ] . Chemical Structure