Vaccine Information: GARDASIL (Page 8 of 8)

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Label ImageLabel Image
GARDASIL human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-1523(NDC:0006-4045)
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 20 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 40 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 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
SODIUM CHLORIDE 9.56 mg 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:50090-1523-1 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (50090-1523-9)
1 NDC:50090-1523-9 .5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (50090-1523-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125126 06/08/2006
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1523)

Revised: 01/2020 A-S Medication Solutions

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.