FDA.reportPublic FDA data

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

RxCUI
798276
RxNorm name
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
Display name
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
Full name
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
Term type
SCD
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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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
30952400-0572-4431-9150-3a41affffb9ahuman papillomavirus quadrivalent (types 6,11,16,18) vaccine, recombinant 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 [SCD] · 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