Label: GARDASIL 9- human papillomavirus 9-valent vaccine, recombinant injection, suspension

  • NDC Code(s): 83703-047-01, 83703-047-02
  • Packager: Bamboo US BidCo LLC
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 17, 2024

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  • PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

    10 Single-dose 0.5-mL Vials

    REFRIGERATE

    Human Papillomavirus 9-valent Vaccine, Recombinant

    GARDASIL ®9

    Suspension for intramuscular injection

    Each 0.5-mL dose contains human papillomavirus L1 protein of each type adsorbed on amorphous aluminum
    hydroxyphosphate sulfate adjuvant as follows:
    Type 6 (30 mcg), Type 11 (40 mcg), Type 16 (60 mcg), Type 18 (40 mcg), Type 31 (20 mcg), Type 33 (20 mcg),
    Type 45 (20 mcg), Type 52 (20 mcg), Type 58 (20 mcg).

    Vaccine is prepared from fermentation cultures of a recombinant strain of yeast Saccharomyces cerevisiae
    containing the genes for the human papillomavirus L1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).

    Contains no preservative or antibiotics.

    Rx only

    PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

  • PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

    10 Single-dose 0.5-mL Syringes

    REFRIGERATE

    Human Papillomavirus
    9-valent Vaccine, Recombinant

    GARDASIL ®9

    Suspension for intramuscular injection

    Each 0.5-mL dose contains human papillomavirus L1 protein of each type
    adsorbed on amorphous aluminum hydroxyphosphate sulfate adjuvant
    as follows:
    Type 6 (30 mcg), Type 11 (40 mcg), Type 16 (60 mcg), Type 18 (40 mcg),
    Type 31 (20 mcg), Type 33 (20 mcg), Type 45 (20 mcg), Type 52 (20 mcg),
    Type 58 (20 mcg).

    Vaccine is prepared from fermentation cultures of a recombinant strain of yeast
    Saccharomyces cerevisiaecontaining the genes for the human papillomavirus
    L1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).

    Contains no preservative or antibiotics.

    Rx only

    PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

  • INGREDIENTS AND APPEARANCE
    GARDASIL 9 
    human papillomavirus 9-valent vaccine, recombinant injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:83703-047
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (UNII: 61746O90DY) (HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN - UNII:61746O90DY) HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN30 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (UNII: Z845VHQ61P) (HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN - UNII:Z845VHQ61P) HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN40 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (UNII: 6LTE2DNX63) (HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN - UNII:6LTE2DNX63) HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN60 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (UNII: J2D279PEM5) (HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN - UNII:J2D279PEM5) HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN40 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN (UNII: 53JIL371NS) (HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN - UNII:53JIL371NS) HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN20 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN (UNII: 759RAC446C) (HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN - UNII:759RAC446C) HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN20 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN (UNII: 68S8VCN34F) (HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN - UNII:68S8VCN34F) HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN20 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN (UNII: 55644W68FD) (HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN - UNII:55644W68FD) HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN20 ug  in 0.5 mL
    HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN (UNII: 94Y15HP7LF) (HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN - UNII:94Y15HP7LF) HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN20 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9.56 mg  in 0.5 mL
    HISTIDINE (UNII: 4QD397987E) 0.78 mg  in 0.5 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 50 ug  in 0.5 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) 35 ug  in 0.5 mL
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white, cloudy) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83703-047-0210 in 1 CARTON
    1NDC:83703-047-010.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA12550812/10/2014
    Labeler - Bamboo US BidCo LLC (119087615)
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