Gardasil 9
NDC 50090-2443

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-2443?
  5. Gardasil 9 Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Gardasil 9 is a BLA-approved product labeled by A-s Medication Solutions. This medication is a vaccine used to prevent cancer of the anus, abnormal tissue growth of the anus, genital warts, or certain head and neck cancers. It is supplied as a white product. This product entry covers the primary NDC 50090-2443 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50090-2443
Proprietary Name:
Gardasil 9
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
8355d971-d377-4d1d-973e-a65798bce7f9
FDA Application Number: [6]
BLA125508
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
12-10-2014
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325 - WHITE, CLOUDY)

Code Structure Chart

Product Details

What is NDC 50090-2443?

The NDC code 50090-2443 is assigned by the FDA to the product Gardasil 9. This pharmaceutical product is labeled by A-s Medication Solutions and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50090-2443-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is a vaccine used to prevent cancer of the anus, abnormal tissue growth of the anus, genital warts, or certain head and neck cancers. In girls and women, it is also used to prevent cancer of the cervix/vagina/vulva and abnormal tissue growth in these areas that can lead to cancer. These conditions are commonly caused by certain types of human papillomavirus (HPV). Vaccines work by increasing the body's natural defense (immunity) against the virus. This vaccine does not protect against all types of HPV, only the types in the vaccine. It is used to prevent the diseases and will not treat active anal/cervical/head/neck/vaginal/vulvar cancer, genital warts, or other diseases caused by the types of HPV in the vaccine.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (UNII: 61746O90DY)
  • HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (UNII: 61746O90DY) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (UNII: Z845VHQ61P)
  • HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (UNII: Z845VHQ61P) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (UNII: 6LTE2DNX63)
  • HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (UNII: 6LTE2DNX63) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (UNII: J2D279PEM5)
  • HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (UNII: J2D279PEM5) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN (UNII: 53JIL371NS)
  • HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN (UNII: 53JIL371NS) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN (UNII: 759RAC446C)
  • HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN (UNII: 759RAC446C) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN (UNII: 68S8VCN34F)
  • HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN (UNII: 68S8VCN34F) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN (UNII: 55644W68FD)
  • HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN (UNII: 55644W68FD) (Active Moiety)
  • HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN (UNII: 94Y15HP7LF)
  • HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN (UNII: 94Y15HP7LF) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1597094 - human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 mL Injection
  • RxCUI: 1597094 - 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML Injection
  • RxCUI: 1597094 - human papillomavirus 9-valent (types 6,11,16,18,31,33,45,52,58) vaccine, recombinant 0.5 ML Injection
  • RxCUI: 1597099 - GARDASIL 9 0.5 ML Injection
  • RxCUI: 1597099 - 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 33 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 45 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 52 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 58 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.06 MG/ML Injection [Gardasil 9]

* Please review the full disclaimer at the bottom of this page.

Patient Education

Human Papillomavirus (HPV) Vaccine


Why get vaccinated? HPV (human papillomavirus) vaccine can prevent infection with some types of human papillomavirus. HPV infections can cause certain types of cancers, including: cervical, vaginal, and vulvar cancer in females penile cancer in males anal cancer in both men and women cancers of tonsils, base of tongue, and back of throat (oropharyngeal cancer) in both men and women HPV infections can also cause anogenital warts. HPV vaccine can prevent over 90% of cancers caused by HPV. HPV is spread through intimate skin-to-skin or sexual contact. HPV infections are so common that nearly all people will get at least one type of HPV at some time in their lives. Most HPV infections go away on their own within 2 years. But sometimes HPV infections will last longer and can cause cancers later in life.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".