BREXAFEMME
These highlights do not include all the information needed to use BREXAFEMME safely and effectively. See full prescribing information for BREXAFEMME . BREXAFEMME (ibrexafungerp tablets ) , for oral use Initial U.S. Approval: 2021
Approved
Approval ID
c33be3a1-c4fd-512c-e053-2995a90a63eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
SCYNEXIS, INC.
DUNS: 001073530
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ibrexafungerp
PRODUCT DETAILS
NDC Product Code75788-115
Application NumberNDA214900
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 1, 2023
Generic Nameibrexafungerp
INGREDIENTS (12)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
IBREXAFUNGERP CITRATEActive
Quantity: 150 mg in 1 1
Code: M4NU2SDX3E
Classification: ACTIM