FDA.reportPublic FDA data

GARDASIL 0.5 ML Prefilled Syringe

RxCUI
798278
RxNorm name
GARDASIL 0.5 ML Prefilled Syringe
Display name
GARDASIL 0.5 ML Prefilled Syringe
Full name
GARDASIL 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125126GardasilHuman Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant351(a)Disc2026-08-01

RxNav Current And Historical NDCs#

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UNII Substances#

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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
30952400-0572-4431-9150-3a41affffb9aGARDASIL 0.5 ML Prefilled Syringe [PSN] · 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.04 MG/ML Prefilled Syringe [Gardasil] [SBD] · Gardasil, Human Papillomavirus Quadrivalent (Types 6,11,16,18) Vaccine, Recombinant 0.5 ML Prefilled Syringe [SY]332These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL. GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] Suspension for intramuscular injection Initial U.S. Approval: 200620250402