NDC 0944-2512

Hyqvia 100 mg per 1 mL / 160 [USP'U] per 1 mL kit

On the label: Takeda Pharmaceuticals America, Inc..

United States: 2Belgium: 1Austria: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Baxalta Belgium Manufacturing SALessines, BelgiumMakes it, tests it and packages it Problems found, fixed voluntarilyJun 18, 2013 · 1 inspection
Baxalta US Inc.Social Circle, GA, United StatesMakes it, tests it and packages it Not inspected on record
Catalent Indiana, LLCBloomington, IN, United StatesMakes the active ingredient Serious problems, FDA actionApr 24, 2026 · 10 inspections, 2 with FDA action
Takeda Manufacturing Austria AGWien, AustriaMakes it Not inspected on record

Product details

Generic drug
Human Immunoglobulin G and Hyaluronidase (human Recombinant): every company that makes it
Form
kit
Strength
100 mg per 1 mL / 160 [USP'U] per 1 mL
Approval
BLA BLA125402
On the market since
Sep 12, 2014
Package NDCs
0944-2512-02 0944-2717-10 0944-2722-03
Official label
DailyMed (National Library of Medicine), updated Jun 18, 2026

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