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
- 65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3
- Product NDC
- 65219-281
- Form
- INJECTION
- Composition / generic term
- Gadobutrol
- Labeler
- Fresenius Kabi USA, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20230414
- Source listing expiry
- 20261231
Source-listed ingredients
- GADOBUTROL — 604.72 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00) · 65219-281-02
- 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03) · 65219-281-07
- 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08) · 65219-281-10
- 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) · 65219-281-15
Source and coverage
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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.
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