Vaccine Information: GARDASIL 9 (Page 8 of 8)

Human Papillomavirus 9-valent Vaccine, Recombinant

Label ImageLabel Image
GARDASIL 9 human papillomavirus 9-valent vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-4958(NDC:0006-4121)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 30 ug in 0.5 mL
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN 40 ug in 0.5 mL
HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN 60 ug in 0.5 mL
HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN) HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 40 ug in 0.5 mL
Human Papillomavirus Type 31 L1 Capsid Protein Antigen (Human Papillomavirus Type 31 L1 Capsid Protein Antigen) Human Papillomavirus Type 31 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 33 L1 Capsid Protein Antigen (Human Papillomavirus Type 33 L1 Capsid Protein Antigen) Human Papillomavirus Type 33 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 45 L1 Capsid Protein Antigen (Human Papillomavirus Type 45 L1 Capsid Protein Antigen) Human Papillomavirus Type 45 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 52 L1 Capsid Protein Antigen (Human Papillomavirus Type 52 L1 Capsid Protein Antigen) Human Papillomavirus Type 52 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 58 L1 Capsid Protein Antigen (Human Papillomavirus Type 58 L1 Capsid Protein Antigen) Human Papillomavirus Type 58 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9.56 mg in 0.5 mL
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (white, cloudy) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4958-1 1 SYRINGE, GLASS in 1 VIAL contains a SYRINGE, GLASS (50090-4958-0)
1 NDC:50090-4958-0 .5 mL in 1 SYRINGE, GLASS This package is contained within the VIAL (50090-4958-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125508 12/10/2014
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4958)

Revised: 05/2023 A-S Medication Solutions

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