Gardasil 9 Injection, Suspension
NDC Package 0006-4119-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) injection is a medication a vaccine used to prevent cancer of the anus, abnormal tissue growth of the anus, genital warts, or certain head and neck cancers. This formulation utilizes a injection, suspension delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-4119 and is authorized under FDA application BLA125508.

Identification & Billing

NDC Package Code
0006-4119-03
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4119-01)
Product Code
0006-4119
11-Digit Billing Format
00006411903
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Gardasil 9
Non-Proprietary Name
Human Papillomavirus 9-valent Vaccine, Recombinant
Substance Name
Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Capsid Protein Antigen; Human Papillomavirus Type 18 L1 Capsid Protein Antigen; Human Papillomavirus Type 31 L1 Capsid Protein Antigen; Human Papillomavirus Type 33 L1 Capsid Protein Antigen; Human Papillomavirus Type 45 L1 Capsid Protein Antigen; Human Papillomavirus Type 52 L1 Capsid Protein Antigen; Human Papillomavirus Type 58 L1 Capsid Protein Antigen; Human Papillomavirus Type 6 L1 Capsid Protein Antigen
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA125508
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-10-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0006-4119-03 identifies a specific commercial package of 10 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose (0006-4119-01) of Gardasil 9, a vaccine label labeled by Merck Sharp & Dohme Llc. This injection, suspension is formulated for intramuscular use and contains human papillomavirus type 11 l1 capsid protein antigen; human papillomavirus type 16 l1 capsid protein antigen; human papillomavirus type 18 l1 capsid protein antigen; human papillomavirus type 31 l1 capsid protein antigen; human papillomavirus type 33 l1 capsid protein antigen; human papillomavirus type 45 l1 capsid protein antigen; human papillomavirus type 52 l1 capsid protein antigen; human papillomavirus type 58 l1 capsid protein antigen; human papillomavirus type 6 l1 capsid protein antigen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Sharp & Dohme Llc on December 10, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006411903. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0006-4119-03
11-Digit CMS (5-4-2)
00006-4119-03

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.