NDC 70461-018

FLUAD

Influenza Vaccine, Adjuvanted

FLUAD is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus, Inc.. The primary component is Influenza A Virus A/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated); Influenza B Virus B/maryland/15/2016 Antigen (formaldehyde Inactivated).

• Product ID: 70461-018_af2d812b-20ae-4fc1-9f5e-349228b250b8
• NDC: 70461-018
• Product Type: Vaccine
• Proprietary Name: FLUAD
• Generic Name: Influenza Vaccine, Adjuvanted
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-07-13
• Marketing End Date: 2019-07-31
• Marketing Category: BLA / BLA
• Application Number: BLA125510
• Labeler Name: Seqirus, Inc.
• Substance Name: INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED)
• Active Ingredient Strength: 15 ug/.5mL; ug/.5mL; ug/.5mL
• NDC Exclude Flag: N

Packaging

NDC 70461-018-03

10 SYRINGE, GLASS in 1 CARTON (70461-018-03) > .5 mL in 1 SYRINGE, GLASS (70461-018-04)

• Marketing Start Date: 2018-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70461-018-04 [70461001804]

Fluad INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125510
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2018-07-13
• Marketing End Date: 2019-07-31

NDC 70461-018-03 [70461001803]

Fluad INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125510
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2018-07-13
• Marketing End Date: 2019-07-31

Drug Details

Active Ingredients

Ingredient	Strength
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	15 ug/.5mL

NDC Crossover Matching brand name "FLUAD" or generic name "Influenza Vaccine, Adjuvanted"

NDC	Brand Name	Generic Name
70461-018	FLUAD	Influenza Vaccine, Adjuvanted
70461-019	FLUAD	Influenza Vaccine, Adjuvanted
70461-020	FLUAD	influenza vaccine, adjuvanted
70461-120	FLUAD QUADRIVALENT	influenza vaccine, adjuvanted
70461-121	FLUAD QUADRIVALENT	influenza vaccine, adjuvanted