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
65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653
Product NDC
65219-088
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

  • 6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 mL in 1 VIAL · 65219-088-50

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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