GARDASIL 9- human papillomavirus 9-valent vaccine, recombinant injection, suspension 
Bamboo US BidCo LLC

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These highlights do not include all the information needed to use GARDASIL 9 safely and effectively. See full prescribing information for GARDASIL 9.

GARDASIL ®9
(Human Papillomavirus 9-valent Vaccine, Recombinant)
Suspension for intramuscular injection
Initial U.S. Approval: 2014

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

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)

Revised: 6/2024
Document Id: 1b19060a-d926-21dd-e063-6394a90a938f
Set id: 1a545aab-fb4a-3f42-e063-6294a90a8351
Version: 2
Effective Time: 20240617
 
Bamboo US BidCo LLC