NDC 65219-281

Gadobutrol 604.72 mg per 1 mL injection

On the label: Fresenius Kabi USA, LLC.

China: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)Lianyungang, ChinaMakes it Serious problems, FDA actionJan 16, 2024 · 5 inspections, 1 with FDA action
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)Lianyungang, ChinaMakes the active ingredient Problems found, fixed voluntarilyApr 15, 2026 · 6 inspections

Product details

Generic drug
Gadolinium Cation (3+): every company that makes it
Form
injection, intravenous
Strength
604.72 mg per 1 mL
Approval
ANDA ANDA215061
On the market since
Apr 14, 2023
Package NDCs
65219-281-00 65219-281-02 65219-281-03 65219-281-05 65219-281-07 65219-281-08 65219-281-10 65219-281-15
Official label
DailyMed (National Library of Medicine), updated Jul 15, 2025

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