gadoterate meglumine
These highlights do not include all the information needed to use GADOTERATE MEGLUMINE INJECTION, USP safely and effectively. See full prescribing information for GADOTERATE MEGLUMINE INJECTION, USP. Gadoterate Meglumine Injection, USP, for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013
Approved
Approval ID
b4159c07-b114-4256-b9a9-e6af811704fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2025
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
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
NDC Product Code70436-123
Application NumberANDA218073
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 16, 2025
Generic Namegadoterate meglumine
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TETRAXETANInactive
Quantity: 0.25 mg in 1 mL
Code: 1HTE449DGZ
Classification: IACT
GADOTERATE MEGLUMINEActive
Quantity: 376.9 mg in 1 mL
Code: L0ND3981AG
Classification: ACTIB