Gardasil Injection, Suspension
NDC Package 0006-4045-41

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

Package Information

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) injection is hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. This formulation utilizes a injection, suspension delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-4045 and is authorized under FDA application BLA125126.

Identification & Billing

NDC Package Code
0006-4045-41
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01)
Product Code
0006-4045
11-Digit Billing Format
00006404541
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 798276 - human papillomavirus quadrivalent (types 6,11,16,18) vaccine, recombinant 0.5 mL Prefilled Syringe
  • RxCUI: 798276 - 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.04 MG/ML Prefilled Syringe
  • RxCUI: 798276 - human papillomavirus quadrivalent (types 6,11,16,18) vaccine, recombinant 0.5 ML Prefilled Syringe
  • RxCUI: 798278 - GARDASIL 0.5 ML Prefilled Syringe
  • RxCUI: 798278 - 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.04 MG/ML / L1 protein, human papillomavirus type 6 vaccine 0.04 MG/ML Prefilled Syringe [Gardasil]

Clinical Specifications

Proprietary Name
Gardasil
Non-Proprietary Name
Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) 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 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
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. [See Description (11).]

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA125126
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-08-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0006-4045). Click a package code to view its specific billing and regulatory data.

0006-4045-00
1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01)

* 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 0006-4045-41 identifies a specific commercial package of 10 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose (0006-4045-01) of Gardasil, 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 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 June 08, 2006. The current certification is valid through December 31, 2026.

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: 00006404541. 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)
0006-4045-41
11-Digit CMS (5-4-2)
00006-4045-41

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