REZZAYO
These highlights do not include all the information needed to use REZZAYO safely and effectively. See full prescribing information for REZZAYO. REZZAYO™ (rezafungin for injection), for intravenous useInitial U.S. Approval: 2023
Approved
Approval ID
90073508-6dca-4d27-aa5a-ed837737c35b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2023
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.
rezafungin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70842-240
Application NumberNDA217417
Product Classification
M
Marketing Category
C73594
G
Generic Name
rezafungin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2022
FDA Product Classification
INGREDIENTS (6)
REZAFUNGINActive
Quantity: 200 mg in 1 1
Code: G013B5478J
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT