<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80777-115-80
</NDCCode>
<PackageDescription>
10 SYRINGE, PLASTIC in 1 CARTON (80777-115-80) / .25 mL in 1 SYRINGE, PLASTIC (80777-115-09)
</PackageDescription>
<NDC11Code>
80777-0115-80
</NDC11Code>
<ProductNDC>
80777-115
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Spikevax
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Covid-19 Vaccine, Mrna
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20260817
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125752
</ApplicationNumber>
<LabelerName>
Moderna US, Inc.
</LabelerName>
<SubstanceName>
CX-055611
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
ug/.25mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-08-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260817
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>