NDC 73475-1221

VYVGART Hytrulo 200 mg per 1 mL / 2000 U per 1 mL injection, solution

On the label: argenx US.

United States: 3Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Avid Bioservices Inc.Tustin, CA, United StatesMakes the active ingredient No problems foundMay 29, 2025 · 7 inspections
Catalent Indiana, LLCBloomington, IN, United StatesMakes the active ingredient Serious problems, FDA actionApr 24, 2026 · 10 inspections, 2 with FDA action
Lonza Biologics, Inc.Portsmouth, NH, United StatesMakes the active ingredient Problems found, fixed voluntarilyFeb 6, 2026 · 8 inspections
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)Ravensburg, GermanyMakes it Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections

Product details

Generic drug
Efgartigimod Alfa and Hyaluronidase (human Recombinant): every company that makes it
Form
injection, solution, subcutaneous
Strength
200 mg per 1 mL / 2000 U per 1 mL
Approval
BLA BLA761304
On the market since
Apr 10, 2025
Package NDCs
73475-1221-1 73475-1221-4
Official label
DailyMed (National Library of Medicine), updated Jul 15, 2026

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