<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0006-4379-02
</NDCCode>
<PackageDescription>
10 AMPULE in 1 CARTON (0006-4379-02) / 2 mL in 1 AMPULE (0006-4379-01)
</PackageDescription>
<NDC11Code>
00006-4379-02
</NDC11Code>
<ProductNDC>
0006-4379
</ProductNDC>
<ProductTypeName>
VACCINE
</ProductTypeName>
<ProprietaryName>
Rotateq
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Rotavirus Vaccine, Live, Oral, Pentavalent
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260515
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125122
</ApplicationNumber>
<LabelerName>
Merck Sharp & Dohme LLC
</LabelerName>
<SubstanceName>
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN
</SubstanceName>
<StrengthNumber>
2200000; 2800000; 2200000; 2000000; 2300000
</StrengthNumber>
<StrengthUnit>
[iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL
</StrengthUnit>
<Pharm_Classes>
Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Live Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Rotavirus Vaccines [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS], Vaccines, Live, Unattenuated [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-05-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260515
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>