Nebupent Inhalant
NDC 63323-877
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Nebupent (pentamidine isethionate) is a NDA-approved product labeled by Fresenius Kabi Usa, Llc. Pentamidine given by inhalation is used to prevent a serious lung infection (Pneumocystis pneumonia-PCP) in people with acquired immunodeficiency syndrome (AIDS). It is supplied as a inhalant for respiratory (inhalation) administration. This product entry covers the primary NDC 63323-877 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
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
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
63323
Product Label ID:
HCPCS Code:
J2545
- PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG
FDA Application Number: [6]
NDA019887
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-15-2011
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 63323-877?
The NDC code 63323-877 is assigned by the FDA to the product Nebupent. It is commonly known by its generic name, pentamidine isethionate. This pharmaceutical product is labeled by Fresenius Kabi Usa, Llc and is currently categorized as listed product. The medication is a inhalant administered via respiratory (inhalation) route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63323-877-15. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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 Active Ingredients of this product?
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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- PENTAMIDINE ISETHIONATE (UNII: V2P3K60DA2)
- PENTAMIDINE (UNII: 673LC5J4LQ) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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 of this product?
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 full disclaimer at the bottom of this page.
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 full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
