Optiray
These highlights do not include all the information needed to use OPTIRAY IMAGING BULK PACKAGE safely and effectively. See full prescribing information for OPTIRAY IMAGING BULK PACKAGE. OPTIRAY (ioversol) Injection for intravenous useInitial U.S. Approval: 1988
Approved
Approval ID
cd718d1c-f813-4114-a50d-c744ff7eb1bf
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0019-1333
Application NumberNDA020923
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ioversol
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateNovember 23, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0019-1332
Application NumberNDA020923
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ioversol
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateNovember 23, 2020
FDA Product Classification
INGREDIENTS (5)
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
IOVERSOLActive
Quantity: 636 mg in 1 mL
Code: N3RIB7X24K
Classification: ACTIB
TROMETHAMINEInactive
Quantity: 3.6 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
Ioversol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0019-1323
Application NumberNDA020923
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ioversol
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRAVENOUS
Effective DateNovember 23, 2020
FDA Product Classification
INGREDIENTS (5)
IOVERSOLActive
Quantity: 678 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