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  4. NDC Product Code: 10122-212 Bronchitol

NDC 10122-212 Bronchitol

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10122-212?
  5. Bronchitol Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
10122-212
Proprietary Name:
Bronchitol
Non-Proprietary Name: [1]
Mannitol
Substance Name: [2]
Mannitol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Labeler Name: [5]
    Chiesi Usa, Inc.
    Labeler Code:
    10122
    Product Label ID:
    454f092e-dcd0-47bd-a521-b07400403dad
    FDA Application Number: [6]
    NDA202049
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-01-2021
    End Marketing Date: [10]
    09-30-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - CLEAR CAPSULE WITH WHITE POWDER)
    Shape:
    CAPSULE (C48336)
    Size(s):
    15 MM
    Imprint(s):
    PXS;40;MG
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 10122-212?

    The NDC code 10122-212 is assigned by the FDA to the product Bronchitol which is a human prescription drug product labeled by Chiesi Usa, Inc.. The generic name of Bronchitol is mannitol. The product's dosage form is capsule and is administered via respiratory (inhalation) form. The product is distributed in 4 packages with assigned NDC codes 10122-212-02 1 blister pack in 1 carton / 10 capsule in 1 blister pack (10122-212-01), 10122-212-04 1 blister pack in 1 carton / 10 capsule in 1 blister pack (10122-212-01), 10122-212-14 14 blister pack in 1 carton / 10 capsule in 1 blister pack (10122-212-01), 10122-212-56 4 carton in 1 box / 14 blister pack in 1 carton (10122-212-14) / 10 capsule in 1 blister pack (10122-212-01). 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 Bronchitol?

    BRONCHITOL is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with Cystic Fibrosis.  Use BRONCHITOL only for adults who have passed the BRONCHITOL Tolerance Test [see Dosage and Administration (2.1)].

    What are Bronchitol 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.
    • MANNITOL 40 mg/1 - A diuretic and renal diagnostic aid related to sorbitol. It has little significant energy value as it is largely eliminated from the body before any metabolism can take place. It can be used to treat oliguria associated with kidney failure or other manifestations of inadequate renal function and has been used for determination of glomerular filtration rate. Mannitol is also commonly used as a research tool in cell biological studies, usually to control osmolarity.

    Which are Bronchitol UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Bronchitol?

    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:

    Which are the Pharmacologic Classes for Bronchitol?

    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.

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    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.

    [10] What 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.

    [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".