FDA.reportPublic FDA data

human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension

RxCUI
798297
RxNorm name
human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension
Display name
human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension
Full name
human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125122RotateqRotavirus Vaccine, Live, Oral, Pentavalent351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
aaf3b24e-85fd-43ee-b657-2ee4df312ec3rotavirus, live pentavalent (RV5) Oral Vaccine [PSN] · human-bovine reassortant rotavirus strain G1 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G2 vaccine 1400000 UNT/ML / human-bovine reassortant rotavirus strain G3 vaccine 1100000 UNT/ML / human-bovine reassortant rotavirus strain G4 vaccine 1000000 UNT/ML / human-bovine reassortant rotavirus strain P1A[8] vaccine 1150000 UNT/ML Oral Suspension [SCD] · rotavirus, live pentavalent (RV5) Oral Vaccine [SY]348These highlights do not include all the information needed to use RotaTeq safely and effectively. See full prescribing information for RotaTeq. RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) oral solution Initial U.S. Approval: 200620260515