Influenza A (h1n1) 2009 Monovalent Vaccine
NDC 66521-200
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Influenza A (h1n1) 2009 Monovalent Vaccine is a BLA-approved product labeled by Novartis Vaccines And Diagnostics Ltd. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 66521-200 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
66521-200
Proprietary Name:
Influenza A (h1n1) 2009 Monovalent Vaccine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
66521
Product Label ID:
FDA Application Number: [6]
BLA103837
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
09-15-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 66521-200?
The NDC code 66521-200 is assigned by the FDA to the product Influenza A (h1n1) 2009 Monovalent Vaccine. This pharmaceutical product is labeled by Novartis Vaccines And Diagnostics Ltd and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 66521-200-02, 66521-200-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: K9P8PVA2UG)
- INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: K9P8PVA2UG) (Active Moiety)
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
