FDA.reportPublic FDA data

INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE

Product NDC
49281-650
11-digit product format
492810650
Labeler code
49281
Product ID
49281-650_3b63f190-7d2d-4fd7-ab3e-b07378f44d93
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA103914
Marketing category
BLA
Marketing start
2009-09-15
Marketing end
0000-00-00
Substance
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
15 ug/.5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49281-650DDiscontinued by firm2026-07-31
excluded packagepackage49281-65049281-650-10DDiscontinued by firm2026-07-31
excluded packagepackage49281-65049281-650-25DDiscontinued by firm2026-07-31
excluded packagepackage49281-65049281-650-50DDiscontinued by firm2026-07-31
excluded packagepackage49281-65049281-650-70DDiscontinued by firm2026-07-31
excluded packagepackage49281-65049281-650-90DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49281-650-102019-10-21C16284748780-1956f9ecf-c462-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial U.S. Approval: 1980
49281-650-252019-10-21C16284748780-1956f9ecf-c462-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial U.S. Approval: 1980
49281-650-502019-10-21C16284748780-1956f9ecf-c462-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial U.S. Approval: 1980
49281-650-702019-10-21C16284748780-1956f9ecf-c462-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial U.S. Approval: 1980
49281-650-902019-10-21C16284748780-1956f9ecf-c462-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine Manufactured by Sanofi Pasteur Inc. Suspension for Intramuscular Injection Initial U.S. Approval: 1980

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-650-10ML - Milliliter49281-65089e6f405-0b09-45f3-97e7-d1999d42019d12013-02-13
49281-650-25ML - Milliliter49281-6502fedb2dc-4413-48a0-a838-2ed0935b797912013-02-13
49281-650-50ML - Milliliter49281-65038a8d7a4-4fe1-41e7-8d42-97157714314a12013-02-13
49281-650-70ML - Milliliter49281-650f2110172-a997-4aab-b01b-8cd1e522092912013-02-13
49281-650-90ML - Milliliter49281-65025a4c82d-2f55-467c-905d-36970695d7d312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT5I5HVC73I8INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE (INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]2
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYEUJ84UN96ZINFLUENZA A (H1N1) 2009 MONOVALENT VACCINE (INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]2
GELATININACTIVE INGREDIENT2G86QN327LINFLUENZA A (H1N1) 2009 MONOVALENT VACCINE (INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]2

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103914Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone QuadrivalentInfluenza Virus Vaccine351(a)Rx2026-06-01