Benznidazole
These highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS. BENZNIDAZOLE tablets, for oral use Initial U.S. Approval: 2017
Approved
Approval ID
8983d6a0-f63f-4f8e-bba4-38223f39e29b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Exeltis USA, Inc.
DUNS: 071170534
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
benznidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0642-7463
Application NumberNDA209570
Product Classification
M
Marketing Category
C73594
G
Generic Name
benznidazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BENZNIDAZOLEActive
Quantity: 12.5 mg in 1 1
Code: YC42NRJ1ZD
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
benznidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0642-7464
Application NumberNDA209570
Product Classification
M
Marketing Category
C73594
G
Generic Name
benznidazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
BENZNIDAZOLEActive
Quantity: 100 mg in 1 1
Code: YC42NRJ1ZD
Classification: ACTIB