United States · FDA National Drug Code directory
Gadobutrol
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 65219-287_d546f4fe-ebb3-47cf-9222-563d15caa8b1
- Product NDC
- 65219-287
- Form
- INJECTION
- Composition / generic term
- Gadobutrol
- Labeler
- Fresenius Kabi USA, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20231001
- Source listing expiry
- 20261231
Source-listed ingredients
- GADOBUTROL — 604.72 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10) · 65219-287-30
Source and coverage
Open FDA National Drug Code directory →
Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
Browse United States records →