GARDASIL 9
These highlights do not include all the information needed to use GARDASIL 9 safely and effectively. See full prescribing information for GARDASIL 9. GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 2014
Approved
Approval ID
a21f4f4b-b891-4f25-b747-cb9ec7d865d6
Product Type
VACCINE LABEL
Effective Date
Mar 25, 2025
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Human Papillomavirus 9-valent Vaccine, Recombinant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-4119
Application NumberBLA125508
Product Classification
M
Marketing Category
C73585
G
Generic Name
Human Papillomavirus 9-valent Vaccine, Recombinant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (15)
Human Papillomavirus Type 6 L1 Capsid Protein AntigenActive
Quantity: 30 ug in 0.5 mL
Code: 61746O90DY
Classification: ACTIB
Human Papillomavirus Type 11 L1 Capsid Protein AntigenActive
Quantity: 40 ug in 0.5 mL
Code: Z845VHQ61P
Classification: ACTIB
Human Papillomavirus Type 16 L1 Capsid Protein AntigenActive
Quantity: 60 ug in 0.5 mL
Code: 6LTE2DNX63
Classification: ACTIB
Human Papillomavirus Type 18 L1 Capsid Protein AntigenActive
Quantity: 40 ug in 0.5 mL
Code: J2D279PEM5
Classification: ACTIB
Human Papillomavirus Type 31 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 53JIL371NS
Classification: ACTIB
Human Papillomavirus Type 33 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 759RAC446C
Classification: ACTIB
Human Papillomavirus Type 45 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 68S8VCN34F
Classification: ACTIB
Human Papillomavirus Type 52 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 55644W68FD
Classification: ACTIB
Human Papillomavirus Type 58 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 94Y15HP7LF
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9.56 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
HISTIDINEInactive
Quantity: 0.78 mg in 0.5 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 50 ug in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BORATEInactive
Quantity: 35 ug in 0.5 mL
Code: 91MBZ8H3QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALUMINUM HYDROXYPHOSPHATE SULFATEInactive
Quantity: 500 ug in 0.5 mL
Code: F41V936QZM
Classification: ADJV
Human Papillomavirus 9-valent Vaccine, Recombinant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-4121
Application NumberBLA125508
Product Classification
M
Marketing Category
C73585
G
Generic Name
Human Papillomavirus 9-valent Vaccine, Recombinant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (15)
Human Papillomavirus Type 6 L1 Capsid Protein AntigenActive
Quantity: 30 ug in 0.5 mL
Code: 61746O90DY
Classification: ACTIB
Human Papillomavirus Type 11 L1 Capsid Protein AntigenActive
Quantity: 40 ug in 0.5 mL
Code: Z845VHQ61P
Classification: ACTIB
Human Papillomavirus Type 16 L1 Capsid Protein AntigenActive
Quantity: 60 ug in 0.5 mL
Code: 6LTE2DNX63
Classification: ACTIB
Human Papillomavirus Type 18 L1 Capsid Protein AntigenActive
Quantity: 40 ug in 0.5 mL
Code: J2D279PEM5
Classification: ACTIB
Human Papillomavirus Type 31 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 53JIL371NS
Classification: ACTIB
Human Papillomavirus Type 33 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 759RAC446C
Classification: ACTIB
Human Papillomavirus Type 45 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 68S8VCN34F
Classification: ACTIB
Human Papillomavirus Type 52 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 55644W68FD
Classification: ACTIB
Human Papillomavirus Type 58 L1 Capsid Protein AntigenActive
Quantity: 20 ug in 0.5 mL
Code: 94Y15HP7LF
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9.56 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
HISTIDINEInactive
Quantity: 0.78 mg in 0.5 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 50 ug in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BORATEInactive
Quantity: 35 ug in 0.5 mL
Code: 91MBZ8H3QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALUMINUM HYDROXYPHOSPHATE SULFATEInactive
Quantity: 500 ug in 0.5 mL
Code: F41V936QZM
Classification: ADJV