Iodixanol
These highlights do not include all the information needed to use IODIXANOL INJECTION safely and effectively. See full prescribing information for IODIXANOL INJECTION. IODIXANOL injection, for intra-arterial or intra-venous use Initial U.S. Approval: 1996
Approved
Approval ID
0fe89ea2-04f7-46c5-9c35-220d8c144a95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
FRESENIUS KABI USA, LLC
DUNS: 013547657
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iodixanol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-383
Application NumberANDA214271
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iodixanol
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Quantity: 1.11 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CALCIUM CHLORIDEInactive
Quantity: 0.044 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
TROMETHAMINEInactive
Quantity: 1.2 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
IODIXANOLActive
Quantity: 320 mg in 1 mL
Code: HW8W27HTXX
Classification: ACTIR
Iodixanol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-381
Application NumberANDA214271
Product Classification
M
Marketing Category
C73584
G
Generic Name
Iodixanol
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (7)
CALCIUM CHLORIDEInactive
Quantity: 0.074 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 1.87 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TROMETHAMINEInactive
Quantity: 1.2 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
IODIXANOLActive
Quantity: 270 mg in 1 mL
Code: HW8W27HTXX
Classification: ACTIR