Conray
2/2023
Approved
Approval ID
1292abfc-496f-4df7-9a08-72072953e1f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2023
Manufacturers
FDA
Liebel-Flarsheim Company LLC
DUNS: 057880002
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iothalamate meglumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0019-0953
Application NumberNDA013295
Product Classification
M
Marketing Category
C73594
G
Generic Name
iothalamate meglumine
Product Specifications
Route of AdministrationINTRAVASCULAR
Effective DateOctober 31, 2019
FDA Product Classification
INGREDIENTS (3)
IOTHALAMATE MEGLUMINEActive
Quantity: 600 mg in 1 mL
Code: XUW72GOP7W
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT