MedPath

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 use Initial U.S. Approval: 2011

Approved
Approval ID

832e0ae1-4fe1-4dff-9978-c9200bcebb55

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 7, 2023

Manufacturers
FDA

Slate Run Pharmaceuticals, LLC

DUNS: 039452765

Products 4

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 Code70436-218
Application NumberANDA217480
Product Classification
M
Marketing Category
C73584
G
Generic Name
gadobutrol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 17, 2025
FDA Product Classification

INGREDIENTS (4)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GADOBUTROLActive
Quantity: 604.72 mg in 1 mL
Code: 1BJ477IO2L
Classification: ACTIB
CALCOBUTROL SODIUMInactive
Code: PO5286589K
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT

gadobutrol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70436-213
Application NumberANDA217480
Product Classification
M
Marketing Category
C73584
G
Generic Name
gadobutrol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 17, 2025
FDA Product Classification

INGREDIENTS (4)

CALCOBUTROL SODIUMInactive
Code: PO5286589K
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GADOBUTROLActive
Quantity: 604.72 mg in 1 mL
Code: 1BJ477IO2L
Classification: ACTIB

gadobutrol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70436-214
Application NumberANDA217480
Product Classification
M
Marketing Category
C73584
G
Generic Name
gadobutrol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 7, 2023
FDA Product Classification

INGREDIENTS (4)

CALCOBUTROL SODIUMInactive
Code: PO5286589K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
GADOBUTROLActive
Quantity: 604.72 mg in 1 mL
Code: 1BJ477IO2L
Classification: ACTIB

gadobutrol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70436-212
Application NumberANDA217480
Product Classification
M
Marketing Category
C73584
G
Generic Name
gadobutrol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 7, 2023
FDA Product Classification

INGREDIENTS (4)

CALCOBUTROL SODIUMInactive
Code: PO5286589K
Classification: IACT
GADOBUTROLActive
Quantity: 604.72 mg in 1 mL
Code: 1BJ477IO2L
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 4/17/2025

WARNINGS AND PRECAUTIONS SECTION

LOINC: 43685-7Updated: 4/17/2025

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 4/17/2025

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

gadobutrol - FDA Drug Approval Details