Pentamidine Isethionate Inhalant
NDC Package 13925-522-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Pentamidine Isethionate inhalants is pentamidine is used to treat a serious lung infection (Pneumocystis pneumonia-PCP) in people with immune system problems, including people with acquired immunodeficiency syndrome (AIDS). This formulation utilizes a inhalant delivery system. Marketed by Seton Pharmaceuticals, this product is identified by NDC 13925-522 and is authorized under FDA application ANDA206667.

Identification & Billing

NDC Package Code
13925-522-01
Package Description
1 VIAL in 1 CARTON / 300 mg in 1 VIAL
Product Code
13925-522
11-Digit Billing Format
13925052201
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

Clinical Specifications

Proprietary Name
Pentamidine Isethionate
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/300mg
Pharmacologic Class
Antiprotozoal - [EPC] (Established Pharmacologic Class)
Usage Information
Pentamidine is used to treat a serious lung infection (Pneumocystis pneumonia-PCP) in people with immune system problems, including 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.

Regulatory & Marketing

Labeler Name
Seton Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA206667
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-14-2019
Listing Expiration
12-31-2026
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: PDAC
PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG
HCPCS Dosage 300 MG
Units / Pkg

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 13925-522-01 identifies a specific commercial package of 1 vial in 1 carton / 300 mg in 1 vial of Pentamidine Isethionate, a human prescription drug labeled by Seton Pharmaceuticals. 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 Seton Pharmaceuticals on October 14, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pentamidine is used to treat a serious lung infection (Pneumocystis pneumonia-PCP) in people with immune system problems, including 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.

How is this Seton Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13925052201. 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)
13925-522-01
11-Digit CMS (5-4-2)
13925-0522-01

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