Umeclidinium And Vilanterol Ellipta Powder
NDC Package 66993-134-97

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

Package Information

Umeclidinium And Vilanterol Ellipta (umeclidinium bromide and vilanterol trifenatate) powders is umeclidinium and Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).Limitations of UseUmeclidinium and Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. This formulation utilizes a powder delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-134 and is authorized under FDA application NDA203975.

Identification & Billing

NDC Package Code
66993-134-97
Package Description
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
Product Code
66993-134
11-Digit Billing Format
66993013497
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: 1487527 - umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1487527 - 30 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1487527 - umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 30 ACTUAT Dry Powder Inhaler

Clinical Specifications

Proprietary Name
Umeclidinium And Vilanterol Ellipta
Non-Proprietary Name
Umeclidinium Bromide And Vilanterol Trifenatate
Substance Name
Umeclidinium Bromide; Vilanterol Trifenatate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Umeclidinium and Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).Limitations of UseUmeclidinium and Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of Umeclidinium and Vilanterol ELLIPTA in asthma have not been established.

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA203975
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
04-11-2025
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 66993-134-97 identifies a specific commercial package of 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler of Umeclidinium And Vilanterol Ellipta, a human prescription drug labeled by Prasco Laboratories. This powder is formulated for respiratory (inhalation) use and contains umeclidinium bromide; vilanterol trifenatate 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 11, 2025. The current certification is valid through December 31, 2026.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993013497. 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)
66993-134-97
11-Digit CMS (5-4-2)
66993-0134-97

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