NDC Code(s) : 70461-201-11, 70461-201-01, 70461-301-12, 70461-301-10
Packager : Seqirus, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like virus), A/Singapore/GP2050/2015 (H3N2) (an A/Hong Kong/4801/2014 - like virus), B/Utah/9/2014 (a B/Phuket/3073/2013-like virus), B/Hong Kong/259/2010 (a B/Brisbane/60/08-like virus) INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70461-201
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: QWJHW3WEXS)
(INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:55QH9PJKDV) 		INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: HRT2X6KFJO)
(INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:41Q3TYMWV2) 		INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: MQM6XOH1SZ)
(INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9VVQ21KI5Z) 		INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: XZF56ICU1B)
(INFLUENZA B VIRUS B/HONG KONG/259/2010 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:56OC384IDL) 		INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70461-201-0110 in 1 CARTON
1NDC:70461-201-110.5 mL in 1 SYRINGE, GLASS 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 BLA125408 07/01/2017 06/30/2018
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL)A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like virus), A/Singapore/GP2050/2015 (H3N2) (an A/Hong Kong/4801/2014 - like virus), B/Utah/9/2014 (a B/Phuket/3073/2013-like virus), B/Hong Kong/259/2010 (a B/Brisbane/60/08-like virus) INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70461-301
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: QWJHW3WEXS)
(INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:55QH9PJKDV) 		INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: HRT2X6KFJO)
(INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:41Q3TYMWV2) 		INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: MQM6XOH1SZ)
(INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9VVQ21KI5Z) 		INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)(UNII: XZF56ICU1B)
(INFLUENZA B VIRUS B/HONG KONG/259/2010 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:56OC384IDL) 		INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
THIMEROSAL(UNII: 2225PI3MOV)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70461-301-101 in 1 CARTON
1NDC:70461-301-125 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125408 07/01/2017 06/30/2018

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 0.5 mL Carton Label

NDC 70461-201-01

For use in persons 4 years of age and older

For intramuscular Injection only

Ten 0.5 mL, single-dose, pre-filled syringes

Rx Only

Influenza Vaccine
FLUCELVAX ®
QUADRIVALENT

2017/2018 SEASON

Principal Display Panel - 0.5 mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 0.5 mL Label

Influenza Vaccine
FLUCELVAX ®
QUADRIVALENT

2017/2018 season

For Intramuscular Injection Only

NDC 70461-201-11

Principal Display Panel - 0.5 mL Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 5 mL Carton Label

Seqirus™

NDC 70461-301-10

5 mL vial

Rx Only

For use in persons 4 years of age and older

For Intramuscular Injection Only

Influenza Vaccine
FLUCELVAX ®
QUADRIVALENT

2017/2018 SEASON

Principal Display Panel - 5 mL Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 5 mL Label

NDC 70461-301-12

Influenza Vaccine
FLUCELVAX ®
QUADRIVALENT

2017-2018 season

5mL vial

Rx only

Principal Display Panel - 5 mL Label