NDC 58160-898-52 Fluarix Quadrivalent 2018/2019

Influenza Virus Vaccine

NDC Package Code 58160-898-52

Field Name Field Value
NDC Code 58160-898-52
Package Description 10 SYRINGE in 1 CARTON > .5 mL in 1 SYRINGE (58160-898-41)
Proprietary Name Fluarix Quadrivalent 2018/2019 Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Influenza Virus Vaccine Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 58160089852 Additional informationCallout TooltipNDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Vaccine Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Glaxosmithkline Biologicals Sa
Dosage Form Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s)
  • Intramuscular - Administration within a muscle.
Active Ingredient(s)
  • INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
Marketing Category BLA - A product marketed under an approved Biologic License Application. Additional informationCallout TooltipWhat 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.
FDA Application Number BLA125127 Additional informationCallout TooltipWhat 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.
Start Marketing Date 06-29-2018 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Start Marketing Date 06-30-2019 Additional informationCallout TooltipWhat is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

The NDC Code 58160-898-52 is assigned to Fluarix Quadrivalent 2018/2019, a vaccine lable labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is suspension and is administered via intramuscular form.


Code Structure
  • 58160 - Glaxosmithkline Biologicals Sa
    • 58160-898 - Fluarix Quadrivalent
      • 58160-898-52 - 10 SYRINGE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 58160-898-52 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
5816008985290686IIV4 VACC NO PRSV 0.5 ML IM0.5 ml0.510110

* Please review the disclaimer below.

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