Fexinidazole
These highlights do not include all the information needed to use FEXINIDAZOLE TABLETS safely and effectively. See full prescribing information for FEXINIDAZOLE TABLETS. FEXINIDAZOLE tablets, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
74a611bc-9977-46bb-b626-0370b3031628
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2023
Manufacturers
FDA
Sanofi-Aventis U.S. LLC
DUNS: 824676584
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexinidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0024-4512
Application NumberNDA214429
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fexinidazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (7)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FEXINIDAZOLEActive
Quantity: 600 mg in 1 1
Code: 306ERL82IR
Classification: ACTIB