FDA.reportPublic FDA data

FLUAD QUADRIVALENT

Product NDC
70461-120
11-digit product format
704610120
Labeler code
70461
Product ID
70461-120_f0c7ba58-6a1e-4d18-b565-ed20882579f3
Type
VACCINE
Nonproprietary name
influenza vaccine, adjuvanted
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Seqirus, Inc.
Application
BLA125510
Marketing category
BLA
Marketing start
2020-02-21
Marketing end
2021-07-31
Substance
INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70461-120-02ML - Milliliter70461-120c04b2791-449c-49c3-aaa5-d2a3bab4984112017-08-11
70461-120-03ML - Milliliter70461-12095162f50-6af4-4338-be5e-c3d69771339112020-07-13
70461-120-04ML - Milliliter70461-1203eecbe8a-871f-4043-b0bd-6b02999650e112020-07-13
70461-120-10ML - Milliliter70461-1206991b5eb-1a64-4268-93e8-06e7a2d4280f12017-08-11
70461-120-11ML - Milliliter70461-12013bd5f52-909d-4f60-b920-d65dd6783d6212017-08-11
70461-120-12ML - Milliliter70461-120458a90f7-43e0-45a9-9470-724a3b12142812017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70461-120-037046101200310 SYRINGE, GLASS in 1 CARTON (70461-120-03) > .5 mL in 1 SYRINGE, GLASS (70461-120-04) 2020-02-212021-07-31NoNoCurrent