Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated) Injection, Solution
NDC Package 63552-192-00

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.

Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated) injection is a licensed vaccine bulk intermediate utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a injection, solution delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-192.

Identification & Billing

NDC Package Code
63552-192-00
Package Description
10 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
Product Code
63552-192
11-Digit Billing Format
63552019200

Clinical Specifications

Proprietary Name
Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)
Non-Proprietary Name
Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)
Substance Name
Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated); Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated); Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated); Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Patheon Manufacturing Services Llc
Product Type
Licensed Vaccine Bulk Intermediate
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
07-01-2022
Listing Expiration
12-31-2027
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 63552-192-00 identifies a specific commercial package of 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass of Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (propiolactone Inactivated), And Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated) (UNFINISHED drug), licensed vaccine bulk intermediate labeled by Patheon Manufacturing Services Llc. This injection, solution is formulated for use and contains influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (propiolactone inactivated); influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (propiolactone inactivated); influenza b virus b/austria/1359417/2021 bvr-26 antigen (propiolactone inactivated); influenza b virus b/phuket/3073/2013 bvr-1b antigen (propiolactone inactivated) 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 July 01, 2022. The current certification is valid through December 31, 2027.

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: 63552019200. 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)
63552-192-00
11-Digit CMS (5-4-2)
63552-0192-00

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