Budesonide Tablet, Extended Release
NDC Package 68682-309-30

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

Package Information

Budesonide tablets is budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a tablet, extended release delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-309 and is authorized under FDA application NDA203634.

Identification & Billing

NDC Package Code
68682-309-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68682-309
11-Digit Billing Format
68682030930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Budesonide
Non-Proprietary Name
Budesonide
Substance Name
Budesonide
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BUDESONIDE 9 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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA203634
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-10-2018
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 68682-309-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Budesonide, a human prescription drug labeled by Oceanside Pharmaceuticals. This tablet, extended release 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 Oceanside Pharmaceuticals on July 10, 2018. 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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682030930. 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)
68682-309-30
11-Digit CMS (5-4-2)
68682-0309-30

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