NDC 80777-401

mNEXSPIKE 10 ug per 0.2 mL injection, suspension

On the label: Moderna US, Inc..

United States: 1Spain: 1

Where it's made

FactoryWhereRoleLast FDA inspection
ModernaTX, Inc.Norwood, MA, United StatesMakes the active ingredient and tests it Not inspected on record
Rovi Pharma Industrial Services S.a.San Sebastián de los Reyes, SpainMakes it and tests it Problems found, fixed voluntarilyJun 3, 2021 · 1 inspection
Moderna Biotech Spain Sl.Madrid, SpainTests it Not inspected on record
ROVI Pharma Industrial Services S.A.Madrid, SpainTests it Problems found, fixed voluntarilyMar 14, 2024 · 6 inspections
Rovi Pharma Industrial Services SAAlcala de Henares, SpainTests it, packages it and labels it Problems found, fixed voluntarilyJan 17, 2024 · 5 inspections

Product details

Generic drug
Cx-055610: every company that makes it
Form
injection, suspension, intramuscular
Strength
10 ug per 0.2 mL
Approval
BLA BLA125835
On the market since
Aug 17, 2026
Package NDCs
80777-401-17 80777-401-60
Official label
DailyMed (National Library of Medicine), updated Aug 17, 2026

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