Uceris Aerosol, Foam
NDC Package 65649-651-03

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

Package Information

Uceris (budesonide) aerosols is a medication used to treat symptoms of a certain bowel disease (ulcerative colitis). This formulation utilizes a aerosol, foam delivery system. Marketed by Salix Pharmaceuticals, Inc., this product is identified by NDC 65649-651 and is authorized under FDA application NDA205613.

Identification & Billing

NDC Package Code
65649-651-03
Package Description
2 CANISTER in 1 CARTON / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)
Product Code
65649-651
11-Digit Billing Format
65649065103
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Uceris
Non-Proprietary Name
Budesonide
Substance Name
Budesonide
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
BUDESONIDE 2 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
Salix Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205613
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2014
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 65649-651-03 identifies a specific commercial package of 2 canister in 1 carton / 1 aerosol, foam in 1 canister (65649-651-02) of Uceris, a human prescription drug labeled by Salix Pharmaceuticals, Inc.. This aerosol, foam is formulated for rectal 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 Salix Pharmaceuticals, Inc. on December 01, 2014. 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 Salix Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65649065103. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
65649-651-03
11-Digit CMS (5-4-2)
65649-0651-03

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