FLUZONE High-Dose

Product NDC: 49281-403
11-digit product format: 492810403
Labeler code: 49281
Product ID: 49281-403_05d5f10c-db65-43ba-a484-3c8b42354154
Type: VACCINE
Nonproprietary name: INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Maryland/15/2016 BX-69A (a B/Colorado/6/2017-like virus) ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Sanofi Pasteur Inc.
Application: BLA103914
Marketing category: BLA
Marketing start: 2018-06-29
Marketing end: 2019-06-30
Substance: INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength: 60 ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49281-403		D	Discontinued by firm		2026-08-17
excluded package	package	49281-403	49281-403-65	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49281-403-65	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49281-403-65	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49281-403-65	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49281-403-65	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49281-403-65	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49281-403-65	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49281-403-65	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49281-403-65	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49281-403-65	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49281-403-65	2025-09-16	C162847	48780-1	2cef2736-a426-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Fluzone ® High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose. Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2019-2020 Formula Initial U.S. Approval: 2009
49281-403-65	2025-01-30	C162847	48780-1	2cef2736-a426-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Fluzone ® High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose. Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2019-2020 Formula Initial U.S. Approval: 2009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49281-403-65	ML - Milliliter	49281-403	506c9a1c-0496-4db4-a3a5-0c295ecbd241	1	2018-08-13
49281-403-88	ML - Milliliter	49281-403	296ddf00-dff1-45fc-9c67-5f89c13c84bd	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49281-403	FLUZONE HIGH-DOSE (INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A (A B/COLORADO/6/2017-LIKE VIRUS) ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]	10	Legacy NDC	20230428_81758772-80b1-4e76-8f50-e68d1fb4e9ee.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103914	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	Rx	2026-07-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8KSK0802BP	INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)
KMO6TK08J4	INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)
M691J375MM	INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)