Visipaque
These highlights do not include all the information needed to use VISIPAQUE safely and effectively. See full prescribing information for VISIPAQUE. VISIPAQUE (iodixanol) injection, for intra-arterial or intra-venous use Initial U.S. Approval: 1996 PHARMACY BULK PACKAGE- NOT FOR DIRECT INFUSION
Approved
Approval ID
2d964c13-88ad-43be-88d4-a3a7ea4d5b5e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2023
Manufacturers
FDA
GE Healthcare Inc.
DUNS: 053046579
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 Code0407-2223
Application NumberNDA020808
Product Classification
M
Marketing Category
C73594
G
Generic Name
Iodixanol
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (5)
IodixanolActive
Quantity: 320 mg in 1 mL
Code: HW8W27HTXX
Classification: ACTIR
Sodium ChlorideInactive
Quantity: 1.11 mg in 1 mL
Code: 451W47IQ8X
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
Edetate Calcium DisodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
Iodixanol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0407-2222
Application NumberNDA020808
Product Classification
M
Marketing Category
C73594
G
Generic Name
Iodixanol
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (5)
Calcium ChlorideInactive
Quantity: 0.074 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
IodixanolActive
Quantity: 270 mg in 1 mL
Code: HW8W27HTXX
Classification: ACTIR
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
Edetate Calcium DisodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT