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  4. NDC Product Code: 63323-877 Nebupent

NDC 63323-877 Nebupent

Pentamidine Isethionate Inhalant Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63323-877?
  4. Nebupent Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes
  9. Patient Education

Product Information

NDC Product Code:
63323-877
Proprietary Name:
Nebupent
Non-Proprietary Name: [1]
Pentamidine Isethionate
Substance Name: [2]
Pentamidine Isethionate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Labeler Name: [5]
    Fresenius Kabi Usa, Llc
    Labeler Code:
    63323
    Product Label ID:
    e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb
    FDA Application Number: [6]
    NDA019887
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-15-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 63323-877-15

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 63323-877?

    The NDC code 63323-877 is assigned by the FDA to the product Nebupent which is a human prescription drug product labeled by Fresenius Kabi Usa, Llc. The generic name of Nebupent is pentamidine isethionate. The product's dosage form is inhalant and is administered via respiratory (inhalation) form. The product is distributed in a single package with assigned NDC code 63323-877-15 1 vial, single-dose in 1 carton / 6 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 Nebupent?

    Pentamidine given by inhalation is used to prevent a serious lung infection (Pneumocystis pneumonia-PCP) in people with acquired immunodeficiency syndrome (AIDS). Pentamidine belongs to a class of drugs known as antiprotozoals. It works by killing the organism that causes the infection.

    What are Nebupent 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 Nebupent UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Nebupent?

    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: 861597 - pentamidine isethionate 300 MG Inhalation Solution
    • RxCUI: 861597 - pentamidine isethionate 50 MG/ML Inhalation Solution
    • RxCUI: 861597 - pentamidine isethionate 300 MG per 6 ML Inhalation Solution
    • RxCUI: 861599 - NebuPent 300 MG Inhalation Solution
    • RxCUI: 861599 - pentamidine isethionate 50 MG/ML Inhalation Solution [NebuPent]

    Which are the Pharmacologic Classes for Nebupent?

    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

    Pentamidine Oral Inhalation


    Pentamidine is an anti-infective agent that helps to treat or prevent pneumonia caused by the organism Pneumocystis jiroveci (carinii). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".