FDA.reportPublic FDA data

FluMist Quadrivalent

Product NDC
66019-307
11-digit product format
660190307
Labeler code
66019
Product ID
66019-307_10232d52-e882-44a4-a84b-5dc4e5f6839a
Type
VACCINE
Nonproprietary name
Influenza Vaccine Live Intranasal
Dosage form
SPRAY
Route
NASAL
Labeler
MedImmune, LLC
Application
BLA125020
Marketing category
BLA
Marketing start
2020-08-10
Marketing end
0000-00-00
Substance
INFLUENZA A VIRUS A/HAWAII/66/2019 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/WASHINGTON/02/2019 LIVE (ATTENUATED) ANTIGEN
Active strength
10000000 [FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66019-307-01EA - Each66019-307156df518-6caf-4df6-9a92-35ec2391881112020-08-06
66019-307-10EA - Each66019-307a4382dae-9592-4ac1-bd52-29691ee42e4912020-08-06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125020Flumist, Flumist QuadInfluenza Vaccine Live, Intranasal351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66019-307-106601903071010 APPLICATOR in 1 PACKAGE (66019-307-10) > .2 mL in 1 APPLICATOR (66019-307-01) 10 applicator2020-08-100000-00-00NoNoCurrent