NDC 70461-321

FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)

Influenza A Virus A/washington/19/2020 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/tasmania/503/2020 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/darwin/7/2019 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)

FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) 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/washington/19/2020 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza A Virus A/tasmania/503/2020 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/darwin/7/2019 Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated).

• Product ID: 70461-321_ccb6cb3a-93ce-478e-abcc-c47608bba6df
• NDC: 70461-321
• Product Type: Vaccine
• Proprietary Name: FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)
• Generic Name: Influenza A Virus A/washington/19/2020 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/tasmania/503/2020 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/darwin/7/2019 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2020-07-02
• Marketing End Date: 2022-07-31
• Marketing Category: BLA /
• Application Number: BLA125408
• Labeler Name: Seqirus Inc.
• Substance Name: INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
• Active Ingredient Strength: 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
• NDC Exclude Flag: N

Packaging

NDC 70461-321-03

10 SYRINGE, GLASS in 1 CARTON (70461-321-03) > .5 mL in 1 SYRINGE, GLASS (70461-321-04)

• Marketing Start Date: 2020-07-02
• Marketing End Date: 2022-07-31
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)" or generic name "Influenza A Virus A/washington/19/2020 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/tasmania/503/2020 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/darwin/7/2019 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)"

NDC	Brand Name	Generic Name
70461-320	FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)	FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)
70461-321	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
70461-421	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)