Budesonide Spray, Metered
NDC Package 49035-703-01

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

Package Information

Budesonide sprays is budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a spray, metered delivery system. Marketed by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc), this product is identified by NDC 49035-703 and is authorized under FDA application ANDA078949.

Identification & Billing

NDC Package Code
49035-703-01
Package Description
1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
49035-703
11-Digit Billing Format
49035070301
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
Non-Proprietary Name
Budesonide
Substance Name
Budesonide
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
BUDESONIDE 32 ug/1
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
Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc)
Product Type
Human Otc Drug
FDA Application #
ANDA078949
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49035-703-01 identifies a specific commercial package of 1 bottle, spray in 1 bottle, spray / 120 spray, metered in 1 bottle, spray of Budesonide, a human over the counter drug labeled by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc). This spray, metered is formulated for nasal 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 Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) on July 01, 2025. The current certification is valid through December 31, 2026.

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 Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035070301. 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)
49035-703-01
11-Digit CMS (5-4-2)
49035-0703-01

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