Budesonide Capsule
NDC Package 0574-9855-10

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

Package Information

Budesonide capsules is budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a capsule delivery system. Marketed by Padagis Us Llc, this product is identified by NDC 0574-9855 and is authorized under FDA application NDA021324.

Identification & Billing

NDC Package Code
0574-9855-10
Package Description
1 BOTTLE in 1 CARTON / 100 CAPSULE in 1 BOTTLE
Product Code
0574-9855
11-Digit Billing Format
00574985510
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: 1244214 - budesonide 3 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Budesonide
Non-Proprietary Name
Budesonide
Substance Name
Budesonide
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BUDESONIDE 3 mg/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
Padagis Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021324
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-29-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0574-9855-10 identifies a specific commercial package of 1 bottle in 1 carton / 100 capsule in 1 bottle of Budesonide, a human prescription drug labeled by Padagis Us Llc. This capsule 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 Padagis Us Llc on June 29, 2018. 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 Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574985510. 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 (4-4-2)
0574-9855-10
11-Digit CMS (5-4-2)
00574-9855-10

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