Nebupent Inhalant
NDC Package 63323-877-15

11-digit billing NDC: 63323087715 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Nebupent (pentamidine isethionate) inhalants is nebuPent is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria:i. a history of one or more episodes of PJPii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies.The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. This formulation utilizes a inhalant delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-877 and is authorized under FDA application NDA019887.

Identification & Billing

NDC Package Code
63323-877-15
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE
Product Code
63323-877
11-Digit Billing Format
63323087715
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Nebupent
Non-Proprietary Name
Pentamidine Isethionate
Substance Name
Pentamidine Isethionate
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
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
PENTAMIDINE ISETHIONATE 300 mg/6mL
Pharmacologic Class
Antiprotozoal - [EPC] (Established Pharmacologic Class)
Usage Information
NebuPent is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria:i. a history of one or more episodes of PJPii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies.The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi’s sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive NebuPent via the Respirgard® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine.The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of NebuPent prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks.No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019887
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-15-2011
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2545
Source: ASP
Pentamidine non-comp unit
HCPCS Dosage 300 MG
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-877-15 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 6 ml in 1 vial, single-dose of Nebupent, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This inhalant is formulated for respiratory (inhalation) use and contains pentamidine isethionate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on February 15, 2011. The current certification is valid through December 31, 2027.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323087715. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63323-877-15
11-Digit CMS (5-4-2)
63323-0877-15

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.