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Gadobutrol

Metadata Updated: February 18, 2026

Gadobutrol is a prescription intravenous contrast agent used to enhance magnetic resonance imaging (MRI) scans, helping doctors visualize body structures more clearly. Manufactured by Fresenius Kabi USA, LLC, it's available in solution form with a concentration of 604.72 mg/mL in vials of 2 mL, 7.5 mL, 10 mL, or 15 mL. This gadolinium-based drug works by improving MRI contrast for better diagnosis. This information was generated using AI and is provided for informational and research purposes only.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date February 18, 2026
Metadata Updated Date February 18, 2026
Data Update Frequency R/P1Y

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date February 18, 2026
Metadata Updated Date February 18, 2026
Publisher U.S. Food and Drug Administration
Maintainer
Identifier ANDA216081
Data First Published 2016-09-16
Data Last Modified 2025-03-17
Category FDA
Public Access Level public
Data Update Frequency R/P1Y
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id f1871edd-0184-44dc-9e7a-231f1916c845
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL https://www.fda.gov/drugs
License https://open.fda.gov/license
Program Code 009:002
Source Datajson Identifier True
Source Hash b8e2f11c75ddae6c02f560c3960ca3ee007d3b05f0671253601f5c8f8e4bb01f
Source Schema Version 1.1

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