Orbactiv
These highlights do not include all the information needed to use ORBACTIV safely and effectively. See full prescribing information for ORBACTIV. ORBACTIV (oritavancin) for injection, for intravenous use Initial U.S. Approval: 2014
Approved
Approval ID
ff09a726-9f9b-4e30-b509-396781293220
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2022
Manufacturers
FDA
Melinta Therapeutics, LLC
DUNS: 079949853
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oritavancin
PRODUCT DETAILS
NDC Product Code70842-140
Application NumberNDA206334
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateFebruary 25, 2022
Generic Nameoritavancin
INGREDIENTS (3)
ORITAVANCINActive
Quantity: 400 mg in 1 1
Code: PUG62FRZ2E
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT