NDC 66521-200

Influenza A (H1N1) 2009 Monovalent Vaccine

Influenza A (h1n1) 2009 Monovalent Vaccine

Influenza A (H1N1) 2009 Monovalent Vaccine is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Novartis Vaccines And Diagnostics Ltd. The primary component is Influenza A Virus A/california/7/2009(h1n1)-like Hemagglutinin Antigen (propiolactone Inactivated).

• Product ID: 66521-200_04366dc0-ba66-11de-a487-0002a5d5c51b
• NDC: 66521-200
• Product Type: Vaccine
• Proprietary Name: Influenza A (H1N1) 2009 Monovalent Vaccine
• Generic Name: Influenza A (h1n1) 2009 Monovalent Vaccine
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2009-09-15
• Marketing Category: BLA / BLA
• Application Number: BLA103837
• Labeler Name: Novartis Vaccines and Diagnostics Ltd
• Substance Name: INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)
• Active Ingredient Strength: 15 ug/.5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 66521-200-02

10 SYRINGE, GLASS in 1 CARTON (66521-200-02) > .5 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2009-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66521-200-02 [66521020002]

Influenza A (H1N1) 2009 Monovalent Vaccine INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103837
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2009-09-15
• Inactivation Date: 2019-10-21

NDC 66521-200-10 [66521020010]

Influenza A (H1N1) 2009 Monovalent Vaccine INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA103837
• Product Type: VACCINE
• Marketing Start Date: 2009-09-15
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)	15 ug/.5mL

NDC Crossover Matching brand name "Influenza A (H1N1) 2009 Monovalent Vaccine" or generic name "Influenza A (h1n1) 2009 Monovalent Vaccine"

NDC	Brand Name	Generic Name
49281-650	INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE	INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)
66521-200	Influenza A (H1N1) 2009 Monovalent Vaccine	Influenza A (H1N1) 2009 Monovalent Vaccine