NDC Code(s) : 70461-120-11, 70461-120-10, 70461-120-12, 70461-120-02
Packager : Seqirus Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FluvirinA/Singapore/GP1908/2015 IVR-180 (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:70461-120
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 (PROPIOLACTONE INACTIVATED)(UNII: V8PC20UBCN)
(INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:WLSRJ8JC6S) 		INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED)(UNII: 3DZY3Q314E)
(INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:C2C4DA5K06) 		INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED)(UNII: 293LSV29OL)
(INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:45E2IPU4MG) 		INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
WATER(UNII: 059QF0KO0R)
THIMEROSAL(UNII: 2225PI3MOV)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70461-120-101 in 1 CARTON
1NDC:70461-120-115 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
2NDC:70461-120-0210 in 1 CARTON
2NDC:70461-120-120.5 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 BLA103837 07/01/2017 06/30/2018

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Fluvirin Injection Multi dose Carton Label

Seqirus™

NDC 70461-120-10

5 mL vial Rx Only

For four years of age and older.

Influenza Virus Vaccine

Fluvirin ® 2017 - 2018 formula

Principal Display Panel - Fluvirin Injection Multi dose Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Fluvirin Injection Multi dose Vial Label

NDC 70461-120-11

INFLUENZA VIRUS
VACCINE Fluvirin ®

2017-2018 formula

5 mL vial

Principal Display Panel - Fluvirin Injection Multi dose Vial Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Fluvirin Injection Prefilled Syringes Carton Label

Seqirus™

10 x 0.5 mL pre-filled syringes

For four years of age and older

Rx Only

NDC 70461-120-02

Influenza Virus Vaccine

Fluvirin ® 2017 - 2018 formula

Principal Display Panel - Fluvirin Injection Prefilled Syringes Carton Label

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Fluvirin Injection Prefilled Syringes Label

0.5 mL

US License No. 2055

NDC 70461-120-12

INFLUENZA VIRUS

VACCINE Fluvirin ®

2017 - 2018 formula

Principal Display Panel - Fluvirin Injection Prefilled Syringes Label