NDC 0173-0681 Relenza

Zanamivir Powder Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0173-0681
Proprietary Name:
Relenza
Non-Proprietary Name: [1]
Zanamivir
Substance Name: [2]
Zanamivir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Labeler Name: [5]
    Glaxosmithkline Llc
    Labeler Code:
    0173
    FDA Application Number: [6]
    NDA021036
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-22-1999
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0173-0681-01

    Package Description: 5 PACKAGE in 1 CARTON / 4 POWDER in 1 PACKAGE

    Price per Unit: $2.81908 per EA

    NDC Code 0173-0681-22

    Package Description: 5 PACKAGE in 1 CARTON / 4 POWDER in 1 PACKAGE

    Product Details

    What is NDC 0173-0681?

    The NDC code 0173-0681 is assigned by the FDA to the product Relenza which is a human prescription drug product labeled by Glaxosmithkline Llc. The generic name of Relenza is zanamivir. The product's dosage form is powder and is administered via respiratory (inhalation) form. The product is distributed in 2 packages with assigned NDC codes 0173-0681-01 5 package in 1 carton / 4 powder in 1 package, 0173-0681-22 5 package in 1 carton / 4 powder in 1 package. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Relenza?

    Zanamivir is used to treat symptoms caused by the flu virus (influenza) if you have had symptoms for 2 days or less. It helps lessen symptoms (such as stuffy nose, cough, sore throat, fever/chills, headache, body aches, tiredness) and shortens the recovery time by about 1 to 2 days. Zanamivir may also be used to prevent the flu if you have been exposed to someone who already has the flu (such as a sick household member) or if there is a flu outbreak in the community. Talk to your doctor for more details. This medication works by stopping the flu virus from growing. It is not a substitute for the flu vaccine. If you have the flu, zanamivir does not reduce the risk of giving the flu to others.

    What are Relenza Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ZANAMIVIR 5 mg/1 - A guanido-neuraminic acid that is used to inhibit NEURAMINIDASE.

    Which are Relenza UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Relenza Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Relenza?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 759471 - zanamivir 5 MG/INHAL Dry Powder Inhaler, 20 Blisters
    • RxCUI: 759471 - 20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler
    • RxCUI: 759471 - zanamivir 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT
    • RxCUI: 759473 - RELENZA DISKHALER 5 MG/INHAL Dry Powder Inhaler, 20 Blisters
    • RxCUI: 759473 - 20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler [Relenza]

    Which are the Pharmacologic Classes for Relenza?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Zanamivir Oral Inhalation


    Zanamivir is used in adults and children at least 7 years of age to treat some types of influenza ('flu') in people who have had symptoms of the flu for less than 2 days. This medication is also used to prevent some types of flu in adults and children at least 5 years of age when they have spent time with someone who has the flu or when there is a flu outbreak. Zanamivir is in a class of medications called neuraminidase inhibitors. It works by stopping the growth and spread of the flu virus in your body. Zanamivir helps shorten the time you have flu symptoms such as nasal congestion, sore throat, cough, muscle aches, tiredness, weakness, headache, fever, and chills.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".