Optiray
These highlights do not include all the information needed to use OPTIRAY safely and effectively. See full prescribing information for OPTIRAY.OPTIRAY (ioversol) injection, for intra-arterial or intra-venous useInitial U.S. Approval: 1988
Approved
Approval ID
549d38db-d4ed-4708-8f76-7cdaa157063f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2023
Manufacturers
FDA
Liebel-Flarsheim Company LLC
DUNS: 057880002
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ioversol
PRODUCT DETAILS
NDC Product Code0019-1332
Application NumberNDA019710
Marketing CategoryC73594
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateFebruary 5, 2023
Generic NameIoversol
INGREDIENTS (3)
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
IOVERSOLActive
Quantity: 636 mg in 1 mL
Code: N3RIB7X24K
Classification: ACTIB
Ioversol
PRODUCT DETAILS
NDC Product Code0019-1333
Application NumberNDA019710
Marketing CategoryC73594
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateFebruary 5, 2023
Generic NameIoversol
INGREDIENTS (5)
IOVERSOLActive
Quantity: 741 mg in 1 mL
Code: N3RIB7X24K
Classification: ACTIB
TROMETHAMINEInactive
Quantity: 3.6 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.2 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Ioversol
PRODUCT DETAILS
NDC Product Code0019-1323
Application NumberNDA019710
Marketing CategoryC73594
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateFebruary 5, 2023
Generic NameIoversol
INGREDIENTS (5)
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.2 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
TROMETHAMINEInactive
Quantity: 3.6 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IOVERSOLActive
Quantity: 678 mg in 1 mL
Code: N3RIB7X24K
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT