NDC 70515-712 Alvesco

Ciclesonide Aerosol, Metered Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
70515-712
Proprietary Name:
Alvesco
Non-Proprietary Name: [1]
Ciclesonide
Substance Name: [2]
Ciclesonide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Labeler Name: [5]
    Covis Pharma Us, Inc
    Labeler Code:
    70515
    FDA Application Number: [6]
    NDA021658
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-26-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 70515-712-01

    Package Description: 1 INHALER in 1 CARTON / 60 AEROSOL, METERED in 1 INHALER

    Price per Unit: $43.16373 per GM

    NDC Code 70515-712-02

    Package Description: 1 INHALER in 1 CARTON / 60 AEROSOL, METERED in 1 INHALER

    NDC Code 70515-712-03

    Package Description: 1 INHALER in 1 CARTON / 30 AEROSOL, METERED in 1 INHALER

    NDC Code 70515-712-04

    Package Description: 1 INHALER in 1 CARTON / 30 AEROSOL, METERED in 1 INHALER

    NDC Code 70515-712-05

    Package Description: 1 INHALER in 1 CARTON / 60 AEROSOL, METERED in 1 INHALER

    Product Details

    What is NDC 70515-712?

    The NDC code 70515-712 is assigned by the FDA to the product Alvesco which is a human prescription drug product labeled by Covis Pharma Us, Inc. The generic name of Alvesco is ciclesonide. The product's dosage form is aerosol, metered and is administered via respiratory (inhalation) form. The product is distributed in 5 packages with assigned NDC codes 70515-712-01 1 inhaler in 1 carton / 60 aerosol, metered in 1 inhaler, 70515-712-02 1 inhaler in 1 carton / 60 aerosol, metered in 1 inhaler, 70515-712-03 1 inhaler in 1 carton / 30 aerosol, metered in 1 inhaler, 70515-712-04 1 inhaler in 1 carton / 30 aerosol, metered in 1 inhaler, 70515-712-05 1 inhaler in 1 carton / 60 aerosol, metered in 1 inhaler. 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 Alvesco?

    Ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Controlling asthma symptoms may decrease time lost from work or school. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. This medication must be taken regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed. Keep track of how often you need to use your quick-relief inhaler, and tell your doctor. If your quick-relief inhaler does not seem to work as well, if you need to use more than usual of your quick-relief inhaler for 2 or more days in a row, or if you need to use more than one full canister of your quick-relief inhaler over a 2-month period, seek immediate medical attention.

    What are Alvesco 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 Alvesco UNII Codes?

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

    Which are Alvesco 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 Alvesco?

    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: 799034 - ciclesonide 160 MCG/INHAL Metered Dose Inhaler, 60 Actuations
    • RxCUI: 799034 - 60 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose Inhaler
    • RxCUI: 799034 - ciclesonide 160 MCG/ACTUAT Metered Dose Inhaler, 60 ACTUAT
    • RxCUI: 799037 - Alvesco 160 MCG/INHAL Metered Dose Inhaler, 60 Actuations
    • RxCUI: 799037 - 60 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose Inhaler [Alvesco]

    * Please review the disclaimer below.

    Patient Education

    Ciclesonide Oral Inhalation


    Ciclesonide oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma in adults and children 12 years of age and older. Ciclesonide is in a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.
    [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".