NDC 69097-168 Arformoterol Tartrate

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

Product Information

NDC Product Code:
69097-168
Proprietary Name:
Arformoterol Tartrate
Non-Proprietary Name: [1]
Arformoterol Tartrate
Substance Name: [2]
Arformoterol Tartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Labeler Name: [5]
    Cipla Usa Inc.
    Labeler Code:
    69097
    FDA Application Number: [6]
    ANDA207306
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-22-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 69097-168-53

    Package Description: 30 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32) / 2 mL in 1 VIAL, SINGLE-DOSE

    Price per Unit: $1.44382 per ML

    NDC Code 69097-168-64

    Package Description: 12 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

    Price per Unit: $1.35242 per ML

    NDC Code 69097-168-87

    Package Description: 6 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48) / 2 mL in 1 VIAL, SINGLE-DOSE

    Price per Unit: $1.44382 per ML

    Product Details

    What is NDC 69097-168?

    The NDC code 69097-168 is assigned by the FDA to the product Arformoterol Tartrate which is a human prescription drug product labeled by Cipla Usa Inc.. The product's dosage form is solution and is administered via respiratory (inhalation) form. The product is distributed in 3 packages with assigned NDC codes 69097-168-53 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch (69097-168-32) / 2 ml in 1 vial, single-dose, 69097-168-64 12 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 2 ml in 1 vial, single-dose, 69097-168-87 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch (69097-168-48) / 2 ml in 1 vial, single-dose. 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 Arformoterol Tartrate?

    Arformoterol is used as a long-term (maintenance) treatment to prevent and decrease wheezing and shortness of breath caused by breathing problems (such as chronic obstructive pulmonary disease, including chronic bronchitis and emphysema). Arformoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Arformoterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (such as albuterol, also known as salbutamol) for sudden shortness of breath while you are using arformoterol. You should always have a quick-relief inhaler with you. Arformoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as arformoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

    What are Arformoterol Tartrate 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.

    Which are Arformoterol Tartrate UNII Codes?

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

    Which are Arformoterol Tartrate 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 Arformoterol Tartrate?

    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: 668956 - arformoterol tartrate 15 MCG in 2 ML Inhalation Solution
    • RxCUI: 668956 - arformoterol 0.0075 MG/ML Inhalation Solution
    • RxCUI: 668956 - arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation Solution
    • RxCUI: 668956 - arformoterol 15 MCG per 2 ML Inhalation Solution

    Which are the Pharmacologic Classes for Arformoterol Tartrate?

    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

    Arformoterol Oral Inhalation


    Arformoterol inhalation is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases, which includes chronic bronchitis and emphysema). Arformoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
    [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".