NDC 76125-679

Koate 1 mL per 1 mL / 1000 [iU] per 10 mL kit

On the label: Kedrion Biopharma, Inc..

United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Grifols Therapeutics LLCClayton, NC, United StatesMakes it Not inspected on record
Grifols Worldwide Operations LimitedClondalkin, IrelandPackages it and labels it Not inspected on record

Product details

Generic drug
Antihemophilic Factor Human and Water: every company that makes it
Form
kit, intravenous
Strength
1 mL per 1 mL / 1000 [iU] per 10 mL
Approval
BLA BLA101130
On the market since
May 20, 1999
Package NDCs
76125-673-51 76125-679-12 76297-002-12
Official label
DailyMed (National Library of Medicine), updated Nov 1, 2026

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