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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75788-115
Application NumberNDA214900
Product Classification
M
Marketing Category
C73594
G
Generic Name
ibrexafungerp
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
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