FDA.reportPublic FDA data

Medical Provider Single Use EZ Flu Shot 2018-2019

Manufacturer
Asclemed USA, Inc.
Effective date
2018-08-31
Label type
VACCINE LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:52:11

Label at a glance#

ProductMedical Provider Single Use EZ Flu Shot 2018-2019
Active ingredientINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTON..., INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTI..., INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), Isopropyl Alcohol
Label structure1 sections

Label contents#

Full prescribing information#

Principal Display Panel - Kit Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76420-521-01 RX-Only

Medical Provider

Single Use EZ Flu Shot™

2018·2019 Formula

Kit Contains:

1 Flucelvax®* Pre-Filled Syringe (0.5 mL)

1 Isopropyl Alcohol 70% Prep Pad

1 Spot Adhesive Bandage

1 Pair Nitrile Powder Free Sterile Gloves (M)

1 Drape

Needle Not Included

1 Dose

Distributed by Enovachem

PHARMACEUTICALS

Torrance, CA 90501

Principal Display Panel - Kit Carton Label
Principal Display Panel - Kit Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76420-521-012022-01-12C16284748780-19d75b9d0-bb72-f424-e053-dadaa90a57ce337a837d-c87d-46f3-a019-12ca7d0a9bcb
76420-521-012020-01-31C16284748780-19d75b9d0-bb72-f424-e053-dadaa90a57ce337a837d-c87d-46f3-a019-12ca7d0a9bcb

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-521-01EA - Each76420-521a3b584f9-3d51-4ab7-99f8-ed12451ee90d12018-10-11
70461-318-03ML - Milliliter70461-318c8a86c38-5dc5-41d2-bbb6-e4ecfd9ffd9912018-09-05
70461-318-04ML - Milliliter70461-318b0c51b09-0131-4d72-af88-f46f3f144b0612018-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-52176420-521-01
70461-31870461-318-03
53329-82053329-820-09

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125408Flucelvax, Flucelvax QuadrivalentInfluenza Vaccine351(a)Disc2026-09-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)QWJHW3WEXSACTIB
INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)HRT2X6KFJOACTIB
INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)MQM6XOH1SZACTIB
INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)XZF56ICU1BACTIB
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
WATER059QF0KO0RIACT
Isopropyl AlcoholND2M416302ACTIB
Water059QF0KO0RIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.