NDC 49281-403

FLUZONE High-Dose

Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a (a B/colorado/6/2017-like Virus) Antigen (formaldehyde Inactivated)

FLUZONE High-Dose is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Influenza A Virus A/michigan/45/2015 X-275 (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 Bx-69a Antigen (formaldehyde Inactivated).

• Product ID: 49281-403_05d5f10c-db65-43ba-a484-3c8b42354154
• NDC: 49281-403
• Product Type: Vaccine
• Proprietary Name: FLUZONE High-Dose
• Generic Name: Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a (a B/colorado/6/2017-like Virus) Antigen (formaldehyde Inactivated)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-06-29
• Marketing End Date: 2019-06-30
• Marketing Category: BLA / BLA
• Application Number: BLA103914
• Labeler Name: Sanofi Pasteur Inc.
• Substance Name: INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (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 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)
• Active Ingredient Strength: 60 ug/.5mL; ug/.5mL; ug/.5mL
• NDC Exclude Flag: N

Packaging

NDC 49281-403-65

10 SYRINGE, GLASS in 1 PACKAGE (49281-403-65) > .5 mL in 1 SYRINGE, GLASS (49281-403-88)

• Marketing Start Date: 2018-06-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49281-403-88 [49281040388]

FLUZONE High-Dose INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103914
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2018-06-29
• Marketing End Date: 2019-06-30

NDC 49281-403-65 [49281040365]

FLUZONE High-Dose INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103914
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2018-06-29
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug/.5mL

NDC Crossover Matching brand name "FLUZONE High-Dose" or generic name "Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a (a B/colorado/6/2017-like Virus) Antigen (formaldehyde Inactivated)"

NDC	Brand Name	Generic Name
49281-403	FLUZONE High-Dose	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Maryland/15/2016 BX-69A (a B/Colorado/6/2017-like virus) ANTIGEN (FORMALDEHYDE INACTIVATED)
49281-405	FLUZONE High-Dose	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Maryland/15/2016 BX-69A (a B/Colorado/6/2017-like virus) ANTIGEN (FORMALDEHYDE INACTIVATED)