Budesonide Capsule, Coated Pellets
NDC Package 70518-4613-0

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, coated pellets delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4613 and is authorized under FDA application ANDA206134.

Identification & Billing

NDC Package Code
70518-4613-0
Package Description
50 POUCH in 1 BOX / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4613-1)
Product Code
70518-4613
11-Digit Billing Format
70518461300
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, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206134
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-23-2026
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 70518-4613-0 identifies a specific commercial package of 50 pouch in 1 box / 1 capsule, coated pellets in 1 pouch (70518-4613-1) of Budesonide, a human prescription drug labeled by Remedyrepack Inc.. This capsule, coated pellets 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 Remedyrepack Inc. on April 23, 2026. 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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518461300. 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 (5-4-1)
70518-4613-0
11-Digit CMS (5-4-2)
70518-4613-00

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