Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Injection, Suspension
NDC Package 63552-212-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) injection is a vaccine. This formulation utilizes a injection, suspension delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-212.

Identification & Billing

NDC Package Code
63552-212-00
Package Description
388 VIAL, SINGLE-DOSE in 1 TRAY / .5 mL in 1 VIAL, SINGLE-DOSE (63552-212-05)
Product Code
63552-212
11-Digit Billing Format
63552021200

Clinical Specifications

Proprietary Name
Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18)
Non-Proprietary Name
Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18)
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.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Patheon Manufacturing Services Llc
Product Type
Vaccine
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-23-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63552-212-00 identifies a specific commercial package of 388 vial, single-dose in 1 tray / .5 ml in 1 vial, single-dose (63552-212-05) of Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) (UNFINISHED drug), a vaccine label labeled by Patheon Manufacturing Services Llc. This injection, suspension is formulated for 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 Patheon Manufacturing Services Llc on December 23, 2024. The current certification is valid through December 31, 2026.

How is this Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552021200. 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 (5-3-2)
63552-212-00
11-Digit CMS (5-4-2)
63552-0212-00

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