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
52fbda34-9974-4f9f-9749-6b17d0495b62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
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 Code70436-216
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 Code70436-217
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
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/17/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/17/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/17/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/17/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/17/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/17/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/17/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 4/17/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/17/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/17/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/17/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/17/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/17/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/17/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/17/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/17/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/17/2025
SPL MEDGUIDE SECTION
LOINC: 42231-1Updated: 4/17/2025