Omnipaque
These highlights do not include all the information needed to use OMNIPAQUE IMAGING BULK PACKAGE safely and effectively. See full prescribing information for OMNIPAQUE IMAGING BULK PACKAGE. OMNIPAQUE (iohexol) injection, for intravenous use Initial U.S. Approval: 1985
Approved
Approval ID
164b27b9-97ae-4279-896f-1c4afa583dd1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2023
Manufacturers
FDA
GE Healthcare
DUNS: 053046579
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iohexol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0407-1413
Application NumberNDA020608
Product Classification
M
Marketing Category
C73594
G
Generic Name
Iohexol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (5)
IohexolActive
Quantity: 300 mg in 1 mL
Code: 4419T9MX03
Classification: ACTIR
edetate calcium disodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
tromethamineInactive
Quantity: 1.21 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Iohexol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0407-1414
Application NumberNDA020608
Product Classification
M
Marketing Category
C73594
G
Generic Name
Iohexol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (5)
tromethamineInactive
Quantity: 1.21 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
IohexolActive
Quantity: 350 mg in 1 mL
Code: 4419T9MX03
Classification: ACTIR
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