Gadobutrol
These highlights do not include all the information needed to use GADOBUTROL INJECTION safely and effectively. See full prescribing information for GADOBUTROL INJECTION. GADOBUTROL injection, for intravenous useInitial U.S. Approval: 2011 IMAGING BULK PACKAGE NOT FOR DIRECT INFUSION
Approved
Approval ID
c0dd1618-0bb3-4974-846b-e5afc2311ae6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gadobutrol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-287
Application NumberANDA216081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gadobutrol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (5)
GadobutrolActive
Quantity: 604.72 mg in 1 mL
Code: 1BJ477IO2L
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
TromethamineInactive
Code: 023C2WHX2V
Classification: IACT
Calcobutrol SodiumInactive
Code: PO5286589K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Gadobutrol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-289
Application NumberANDA216081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gadobutrol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (5)
GadobutrolActive
Quantity: 604.72 mg in 1 mL
Code: 1BJ477IO2L
Classification: ACTIB
TromethamineInactive
Code: 023C2WHX2V
Classification: IACT
Calcobutrol SodiumInactive
Code: PO5286589K
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT