Budesonide
NDC Package 60687-421-25

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. Marketed by American Health Packaging, this product is identified by NDC 60687-421 and is authorized under FDA application ANDA207367.

Identification & Billing

NDC Package Code
60687-421-25
Package Description
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE in 1 BLISTER PACK (60687-421-95)
Product Code
60687-421
11-Digit Billing Format
60687042125
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Budesonide
Dosage Form
-
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
American Health Packaging
FDA Application #
ANDA207367
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-18-2018
End Marketing Date
05-31-2020
Listing Expiration
05-31-2020
Exclude Flag
D
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 60687-421-25 identifies a specific commercial package of 30 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack (60687-421-95) of Budesonide, labeled by American Health Packaging. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by American Health Packaging on December 18, 2018. The current certification is valid through May 31, 2020.

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 American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60687042125. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
60687-421-25
11-Digit CMS (5-4-2)
60687-0421-25

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