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

GARDASIL 9 by

Drug Labeling and Warnings

GARDASIL 9 by is a Other medication manufactured, distributed, or labeled by Bamboo US BidCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-047
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 ANTIGEN	30 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 ANTIGEN	40 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 ANTIGEN	60 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 ANTIGEN	40 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 ANTIGEN	20 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 ANTIGEN	20 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 ANTIGEN	20 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 ANTIGEN	20 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 ANTIGEN	20 ug  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white, cloudy)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83703-047-02	10 in 1 CARTON
1	NDC: 83703-047-01	0.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125508	12/10/2014

Labeler - Bamboo US BidCo LLC (119087615)