NDC Code(s) : 42874-117-01, 42874-117-10
Packager : Protein Sciences Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Flublok Quadrivalentinfluenza vaccine INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42874-117
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN(UNII: 69H0YJ871T)
(INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:69H0YJ871T) 		INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN45 ug in 0.5 mL
INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN(UNII: 2I1EOL437M)
(INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:2I1EOL437M) 		INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN45 ug in 0.5 mL
INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN(UNII: 058U2312CR)
(INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:058U2312CR) 		INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN45 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN(UNII: POQ8DQO9S3)
(INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:POQ8DQO9S3) 		INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN45 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(UNII: E1W4N241FO)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYSORBATE 20(UNII: 7T1F30V5YH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42874-117-1010 in 1 CARTON
1NDC:42874-117-010.5 mL in 1 VIAL, SINGLE-DOSE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125285 07/14/2017 06/30/2018

PRINCIPAL DISPLAY PANEL

Flublok Quadrivalent 2017-2018 Carton LabelCarton Label

Influenza Vaccine
FLUBLOK® QUADRIVALENT
2017/2018 Formula

NDC 42874-117-10

Rx only

10 Disposable Prefilled Luer-Lok® Syringes
each containing one 0.5 mL dose

No Thimerosal or other preservatives

For 18 Years of Age and Older

NEEDLES NOT INCLUDED
FOR INTRAMUSCULAR ADMINISTRATION ONLY

Protein Sciences Corporation

Store refrigerated at 2° to 8°C (36° to 46°F)
For intramuscular administration only.
DO NOT FREEZE. Discard if frozen.
Protect syringe from light.

Each 0.5 mL dose is formulated to contain 45 mcg of recombinant
hemagglutinin (HA) derived from each of the following influenza virus strains:
A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2),
B/Brisbane/60/2008, and B/Phuket/3073/2013. The recombinant HAs are
produced in cultured cells and formulated with phosphate buffered saline and
27.5 mcg per dose polysorbate 20 (Tween® 20). Contains no preservative.
See prescribing information for additional details.

The tip caps and plungers of the prefilled syringes are not made with natural
rubber latex.

LUER-LOK is a registered trademark of Becton, Dickinson and Company.

Manufactured by Protein Sciences Corporation
Meriden, CT 06450

US License # 1795

PRINCIPAL DISPLAY PANEL

Flublok Quadrivalent 2017-2018 Vial LabelVial Label

LOT No.:

EXP Date:

Influenza Vaccine
FLUBLOK® QUADRIVALENT
2017-2018 Formula
No Preservative

1 Dose (0.5 mL)

Rx only

NDC 42874-117-01

For Intramuscular Injection

Protein Sciences Corporation
US License # 1795

(01)00342874117010