NDC Code(s) : 70461-002-11, 70461-002-01
Packager : Seqirus Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FLUADA/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015 (H1N1)pdm09-like virus), A/Hong Kong/4801/2014, NYMC X-263B (H3N2) (an A/Hong Kong/4801/2014-like virus), and B/Brisbane/60/2008, wild type (a B/Brisbane/60/2008-like virus) INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70461-002
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 (FORMALDEHYDE INACTIVATED)(UNII: Q3P251C5MT)
(INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:LD80H821HF) 		INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug in 0.5 mL
INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: WSU74R91RL)
(INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:BAA3UN7VWD) 		INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug in 0.5 mL
INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: W45Z4CJE2J)
(INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:166D8OWM7B) 		INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride(UNII: 451W47IQ8X)
potassium chloride(UNII: 660YQ98I10)
potassium phosphate, monobasic(UNII: 4J9FJ0HL51)
sodium phosphate, dibasic, dihydrate(UNII: 94255I6E2T)
magnesium chloride(UNII: 02F3473H9O)
calcium chloride(UNII: M4I0D6VV5M)
citric acid monohydrate(UNII: 2968PHW8QP)
sorbitan trioleate(UNII: QE6F49RPJ1)
trisodium citrate dihydrate(UNII: B22547B95K)
water(UNII: 059QF0KO0R)
squalene(UNII: 7QWM220FJH)
polysorbate 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70461-002-0110 in 1 CARTON
1NDC:70461-002-110.5 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 BLA125510 07/01/2017 06/30/2018

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Fluad Carton Label

NDC 70641-002-01

2017/2018 SEASON

Influenza
Vaccine,
Adjuvanted
FLUAD ®

For adults 65 years
of age and older

For Intramuscular Injection Only

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

Rx Only

Principal Display Panel - Fluad Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Fluad Label

Influenza Vaccine, Adjuvanted

FLUAD® 2017/2018 season

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