Budesonide Inhalant
NDC Package 69097-321-53

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

Package Information

Budesonide inhalants is budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a inhalant delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-321 and is authorized under FDA application ANDA205710.

Identification & Billing

NDC Package Code
69097-321-53
Package Description
30 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH (69097-321-32) / 2 mL in 1 AMPULE
Product Code
69097-321
11-Digit Billing Format
69097032153
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Budesonide Inhalation Suspension
Non-Proprietary Name
Budesonide
Substance Name
Budesonide
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BUDESONIDE 1 mg/2mL
Pharmacologic Class
Usage Information
Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

Regulatory & Marketing

Labeler Name
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205710
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-16-2017
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.

J7626
Source: ASP
Budesonide non-comp unit
HCPCS Dosage UP TO 0.50 MG
Units / Pkg 60

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69097-321). Click a package code to view its specific billing and regulatory data.

69097-321-87
6 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH (69097-321-86) / 2 mL in 1 AMPULE

* 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 69097-321-53 identifies a specific commercial package of 30 pouch in 1 carton / 1 ampule in 1 pouch (69097-321-32) / 2 ml in 1 ampule of Budesonide Inhalation Suspension, a human prescription drug labeled by Cipla Usa Inc.. This inhalant is formulated for oral use and contains budesonide 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 Cipla Usa Inc. on November 16, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097032153. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
69097-321-53
11-Digit CMS (5-4-2)
69097-0321-53

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