Umeclidinium Ellipta Aerosol, Powder
NDC Package 66993-189-97

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

Package Information

Umeclidinium Ellipta (umeclidinium) aerosols is umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). This formulation utilizes a aerosol, powder delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-189 and is authorized under FDA application NDA205382.

Identification & Billing

NDC Package Code
66993-189-97
Package Description
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER
Product Code
66993-189
11-Digit Billing Format
66993018997
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1539251 - umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1539251 - 30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler

Clinical Specifications

Proprietary Name
Umeclidinium Ellipta
Non-Proprietary Name
Umeclidinium
Substance Name
Umeclidinium Bromide
Dosage Form
Aerosol, Powder - A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
UMECLIDINIUM BROMIDE 62.5 ug/1
Pharmacologic Class
Usage Information
Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA205382
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
04-06-2026
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 66993-189-97 identifies a specific commercial package of 1 tray in 1 carton / 1 inhaler in 1 tray / 30 aerosol, powder in 1 inhaler of Umeclidinium Ellipta, a human prescription drug labeled by Prasco Laboratories. This aerosol, powder is formulated for oral use and contains umeclidinium bromide 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 Prasco Laboratories on April 06, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993018997. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
66993-189-97
11-Digit CMS (5-4-2)
66993-0189-97

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