NDC 65219-088

Gadoterate Meglumine 376.9 mg per 1 mL injection

On the label: Fresenius Kabi USA, LLC.

China: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)Lianyungang, ChinaMakes it Problems found, fixed voluntarilyAug 29, 2023 · 2 inspections

Product details

Generic drug
Gadolinium Cation (3+): every company that makes it
Form
injection, intravenous
Strength
376.9 mg per 1 mL
Approval
ANDA ANDA215982
On the market since
Jun 20, 2022
Package NDCs
65219-088-06 65219-088-50
Official label
DailyMed (National Library of Medicine), updated Nov 7, 2025

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