NDC 65219-646

Protamine Sulfate 10 mg per 1 mL injection, solution

On the label: Fresenius Kabi USA, LLC.

United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Fresenius Kabi USA, LLCMelrose Park, IL, United StatesMakes it and tests it Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action

Product details

Generic drug
Protamine: every company that makes it
Form
injection, solution, intravenous
Strength
10 mg per 1 mL
Approval
ANDA ANDA089454
On the market since
Mar 28, 2025
Package NDCs
65219-646-02 65219-646-05
Official label
DailyMed (National Library of Medicine), updated Apr 29, 2025

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