Influenza A (H1N1) 2009 Monovalent Vaccine

Product NDC: 66521-200
11-digit product format: 665210200
Labeler code: 66521
Product ID: 66521-200_04366dc0-ba66-11de-a487-0002a5d5c51b
Type: VACCINE
Nonproprietary name: Influenza A (H1N1) 2009 Monovalent Vaccine
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Novartis Vaccines and Diagnostics Ltd
Application: BLA103837
Marketing category: BLA
Marketing start: 2009-09-15
Marketing end: 0000-00-00
Substance: INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66521-200		I	Inactivated by FDA	2026-07-31
excluded package	package	66521-200	66521-200-02	I	Inactivated by FDA	2026-07-31
excluded package	package	66521-200	66521-200-10	I	Inactivated by FDA	2026-07-31

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66521-200-02	2019-10-21	C162847	48780-1	956f9ecf-d28a-621f-e053-dbdaa90a74ad	These 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 Novartis Vaccines and Diagnostics Ltd. Suspension for Intramuscular Injection Initial U.S. Approval: 2009
66521-200-10	2019-10-21	C162847	48780-1	956f9ecf-d28a-621f-e053-dbdaa90a74ad	These 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 Novartis Vaccines and Diagnostics Ltd. Suspension for Intramuscular Injection Initial U.S. Approval: 2009

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66521-200-02	Influenza A (H1N1) 2009 Monovalent Vaccine	10 in 1 CARTON	INJECTION, SUSPENSION	10	3
66521-200-02	Influenza A (H1N1) 2009 Monovalent Vaccine	0.5 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION	0.5	3
66521-200-10	Influenza A (H1N1) 2009 Monovalent Vaccine	1 in 1 CARTON	INJECTION, SUSPENSION	1	3
66521-200-10	Influenza A (H1N1) 2009 Monovalent Vaccine	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	5	3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66521-200-02	ML - Milliliter	66521-200	52c5cec3-6196-40e2-a8c8-d3dd88c020af	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)	ACTIVE INGREDIENT	K9P8PVA2UG	INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE INJECTION, SUSPENSION [NOVARTIS VACCINES AND DIAGNOSTICS LTD]	3
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)	ACTIVE MOIETY	K9P8PVA2UG	INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE INJECTION, SUSPENSION [NOVARTIS VACCINES AND DIAGNOSTICS LTD]	3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66521-200	INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE INJECTION, SUSPENSION [NOVARTIS VACCINES AND DIAGNOSTICS LTD]	3	Legacy NDC, 4 package rows	20091023_fc5cfd1c-1ff5-4cfa-b544-db8d7f26d46f.zip

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103837	Fluvirin	Influenza Virus Vaccine	351(a)	Disc	2026-06-01

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66521-200-02	66521020002	10 in 1 CARTON	Historical
66521-200-10	66521020010	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Influenza A (H1N1) 2009 Monovalent Vaccine	Novartis Vaccines and Diagnostics Ltd	2009-10-16	VACCINE LABEL	3