# Gadoterate Meglumine

NDC: 65219-080
Generic name: gadoterate meglumine
Labeler / Manufacturer: Fresenius Kabi USA, LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: INJECTION
Routes: INTRAVENOUS
Marketing started: 20220620

FDA application: ANDA215304

## Active ingredients

- GADOTERATE MEGLUMINE: 376.9 mg/mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"65219-080"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=65219-080
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e0655aac-9508-4141-94f5-fcca6af1c41d