United States · FDA National Drug Code directory
Gadoterate Meglumine
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
- 65219-084_f05922b7-99d4-48c7-972a-7966bbbbc3b4
- Product NDC
- 65219-084
- Form
- INJECTION
- Composition / generic term
- gadoterate meglumine
- Labeler
- Fresenius Kabi USA, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20220620
- Source listing expiry
- 20261231
Source-listed ingredients
- GADOTERATE MEGLUMINE — 376.9 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 10 CARTON in 1 BOX (65219-084-15) / 1 VIAL in 1 CARTON (65219-084-01) / 15 mL in 1 VIAL · 65219-084-15
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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