DEFENCATH
These highlights do not include all the information needed to use DEFENCATH safely and effectively. See full prescribing information for DEFENCATH. DEFENCATH (taurolidine and heparin) catheter lock solution, for central venous catheter instillation useInitial U.S. Approval: 2023LIMITED POPULATION
Approved
Approval ID
13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
CorMedix Inc.
DUNS: 849818831
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
taurolidine and heparin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72990-103
Application NumberNDA214520
Product Classification
M
Marketing Category
C73594
G
Generic Name
taurolidine and heparin
Product Specifications
Route of AdministrationINTRALUMINAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS CITRIC ACIDInactive
Quantity: 78.3 mg in 3 mL
Code: XF417D3PSL
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TAUROLIDINEActive
Quantity: 40.5 mg in 3 mL
Code: 8OBZ1M4V3V
Classification: ACTIB
HEPARINActive
Quantity: 3000 [USP'U] in 3 mL
Code: T2410KM04A
Classification: ACTIB
taurolidine and heparin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72990-105
Application NumberNDA214520
Product Classification
M
Marketing Category
C73594
G
Generic Name
taurolidine and heparin
Product Specifications
Route of AdministrationINTRALUMINAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS CITRIC ACIDInactive
Quantity: 130.5 mg in 5 mL
Code: XF417D3PSL
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TAUROLIDINEActive
Quantity: 67.5 mg in 5 mL
Code: 8OBZ1M4V3V
Classification: ACTIB
HEPARINActive
Quantity: 5000 [USP'U] in 5 mL
Code: T2410KM04A
Classification: ACTIB