CLARISCAN
These highlights do not include all the information needed to use CLARISCAN safely and effectively. See full prescribing information for CLARISCAN. CLARISCAN™ (gadoterate meglumine) injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013
Approved
Approval ID
c9e273b3-481f-4899-8913-95aaddcc7662
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
GE Healthcare
DUNS: 053046579
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gadoterate meglumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0407-2943
Application NumberANDA210016
Product Classification
M
Marketing Category
C73584
G
Generic Name
gadoterate meglumine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 30, 2022
FDA Product Classification
INGREDIENTS (3)
GADOTERATE MEGLUMINEActive
Quantity: 376.9 mg in 1 mL
Code: L0ND3981AG
Classification: ACTIM
WATERInactive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT
TETRAXETANInactive
Quantity: 0.25 mg in 1 mL
Code: 1HTE449DGZ
Classification: IACT