NDC 13533-636

Hyperhep B 220 [iU] per 1 mL injection

On the label: Grifols Usa, LLC.

United States: 1Spain: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Grifols Therapeutics LLCClayton, NC, United StatesMakes it Not inspected on record
Instituto Grifols, S.A.Parets Del Valles, SpainMakes it Not inspected on record
Grifols Worldwide Operations LimitedClondalkin, IrelandPackages it and labels it Not inspected on record

Product details

Generic drug
Human Hepatitis B Virus Immune Globulin: every company that makes it
Form
injection, intramuscular
Strength
220 [iU] per 1 mL
Approval
BLA BLA101146
On the market since
Oct 9, 1996
Package NDCs
13533-636-01 13533-636-02 13533-636-03 13533-636-05 13533-636-10 13533-636-20 13533-636-30 13533-636-50
Official label
DailyMed (National Library of Medicine), updated Nov 1, 2026

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