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

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	81758772-80b1-4e76-8f50-e68d1fb4e9ee
49281-403-65	2025-01-30	C162847	48780-1	2cef2736-a426-d83d-e063-dadaa90ab31f	81758772-80b1-4e76-8f50-e68d1fb4e9ee

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

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

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)