FLUZONE QUADRIVALENT

Product NDC: 49281-518
11-digit product format: 492810518
Labeler code: 49281
Product ID: 49281-518_984eb649-46da-4e17-9cf1-8d560d975379
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), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Sanofi Pasteur Inc.
Application: BLA103914
Marketing category: BLA
Marketing start: 2019-01-23
Marketing end: 0000-00-00
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/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength: 8 ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49281-518-00	ML - Milliliter	49281-518	f50f2c22-ff88-4cc9-bb6f-ef1ef3cd1114	1	2018-08-13
49281-518-25	ML - Milliliter	49281-518	f295f8cd-2c8b-440e-8f3f-7a729b8658ee	1	2018-08-13

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	2026-06-01

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)
B93BQX9789	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)	INFLUENZA B VIRUS B/PHUKET/3073/2013 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)