Is Moderna US, Inc. FDA approved?

Moderna US, Inc. holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Moderna US, Inc.'s drugs manufactured?

At registered sites in Spain, the United States. The FDA register lists MADRID; Norwood, MA. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Moderna US, Inc. make?

8 products are listed under Moderna US, Inc. in the openFDA NDC Directory, most often as injection, suspension; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Moderna US, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 8
Labeller names: 2
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MODERNA BIOTECH SPAIN SL.Registrant: Moderna US, Inc.	CALLE JULIAN CAMARILLO 31, MADRID, 28037, Spain (ESP)	Analytical testing	3030155316469713566
ModernaTX, Inc.Registrant: Moderna US, Inc.	One Moderna Way, Norwood, Massachusetts (MA) 02062, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3014937058116912313

Catalogue

Drug listings by form and route

8 active NDC listings: 8 vaccine. By marketing category: BLA 8.

Dosage form	NDCs
injection, suspension	7
suspension	1

Route	NDCs
intramuscular	8

Labeller name on the listing	NDCs
moderna us, inc.	7
moderna us, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Spikevax	COVID-19 Vaccine, mRNA	injection, suspension, intramuscular	80777-112BLA
Spikevax	COVID-19 Vaccine, mRNA	injection, suspension, intramuscular	80777-113BLA
Spikevax	COVID-19 Vaccine, mRNA	injection, suspension, intramuscular	80777-114BLA
Spikevax	COVID-19 Vaccine, mRNA	injection, suspension, intramuscular	80777-115BLA
mFLUSIVA	Influenza Vaccine, mRNA	injection, suspension, intramuscular	80777-500BLA
mNEXSPIKE	COVID-19 Vaccine, mRNA	injection, suspension, intramuscular	80777-400BLA
mNEXSPIKE	COVID-19 Vaccine, mRNA	injection, suspension, intramuscular	80777-401BLA
mRESVIA	Respiratory Syncytial Virus Vaccine	suspension, intramuscular	80777-345BLA

Neighbours

Registered in the same town

Eli Lilly and CompanyMadrid, ESP
ROVI Pharma Industrial Services S.A.Madrid, ESP
Alk-Abello, Inc.MADRID, ESP
LABORATORIOS FARMACEUTICOS ROVI S.A.Madrid, ESP

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AmerisourceBergen Drug Corporation2 sites · 47 NDC
Genus Lifesciences Inc.2 sites · 46 NDC

Enquiry

Common questions

Is Moderna US, Inc. FDA approved?: Moderna US, Inc. holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Moderna US, Inc.'s drugs manufactured?: At registered sites in Spain, the United States. The FDA register lists MADRID; Norwood, MA. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Moderna US, Inc. make?: 8 products are listed under Moderna US, Inc. in the openFDA NDC Directory, most often as injection, suspension; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.