Uceris Tablet, Extended Release
NDC Package 68012-309-01

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

Package Information

Uceris (budesonide) tablets is a medication used to treat symptoms of a certain bowel disease (ulcerative colitis). This formulation utilizes a tablet, extended release delivery system. Marketed by Santarus Inc., this product is identified by NDC 68012-309 and is authorized under FDA application NDA203634.

Identification & Billing

NDC Package Code
68012-309-01
Package Description
2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
68012-309
11-Digit Billing Format
68012030901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Uceris
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
This medication is used to treat symptoms of a certain bowel disease (ulcerative colitis). It works by reducing swelling (inflammation). Budesonide belongs to a class of drugs known as corticosteroids. Budesonide does not cure ulcerative colitis, but it may help relieve symptoms such as abdominal pain, diarrhea, and bloody stools. Using this medication as a foam allows it to work directly on the bowel and rectum.

Regulatory & Marketing

Labeler Name
Santarus Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203634
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-14-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68012-309). Click a package code to view its specific billing and regulatory data.

68012-309-02
2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
68012-309-30
30 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 68012-309-01 identifies a specific commercial package of 2 tablet, extended release in 1 blister pack of Uceris, a human prescription drug labeled by Santarus Inc.. 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 Santarus Inc. on January 14, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat symptoms of a certain bowel disease (ulcerative colitis). It works by reducing swelling (inflammation). Budesonide belongs to a class of drugs known as corticosteroids. Budesonide does not cure ulcerative colitis, but it may help relieve symptoms such as abdominal pain, diarrhea, and bloody stools. Using this medication as a foam allows it to work directly on the bowel and rectum.

How is this Santarus Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68012030901. 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)
68012-309-01
11-Digit CMS (5-4-2)
68012-0309-01

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