63552-192 NDC - 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)

Drug Information

  • Product NDC: 63552-192
  • Proprietary Name:
  • 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)
  • Active Ingredient(s): 15 ug/.5mL INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); 15 ug/.5mL INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); 15 ug/.5mL INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED); 15 ug/.5mL INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)
  • Administration Route(s):
  • Dosage Form(s): INJECTION, SOLUTION

Labeler Information

Field Name Field Value
Labeler Name: Patheon Manufacturing Services LLC
Product Type: LICENSED VACCINE BULK INTERMEDIATE
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:7/1/2022

Package Information

No. Package Code Package Description Billing Unit
163552-192-0010 SYRINGE, GLASS in 1 CARTON (63552-192-00) / .5 mL in 1 SYRINGE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC63552-192The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMELICENSED VACCINE BULK INTERMEDIATEIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMEinfluenza 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)The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE7/1/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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.
LABELER NAMEPatheon Manufacturing Services LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEINFLUENZA 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)An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH15; 15; 15; 15 
ACTIVE INGRED UNITug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 

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This page was last updated on: 11/21/2025

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