Fluticasone Furoate And Vilanterol Powder
NDC Package 66993-135-97

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

Package Information

Fluticasone Furoate And Vilanterol powders is the use of Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions (5.11), Description (11)]. This formulation utilizes a powder delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-135 and is authorized under FDA application NDA204275.

Identification & Billing

NDC Package Code
66993-135-97
Package Description
1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
Product Code
66993-135
11-Digit Billing Format
66993013597
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: 1424889 - fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1424889 - 30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1648788 - fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
  • RxCUI: 1648788 - 30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1648788 - fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT

Clinical Specifications

Proprietary Name
Fluticasone Furoate And Vilanterol
Non-Proprietary Name
Fluticasone Furoate And Vilanterol
Substance Name
Fluticasone Furoate; 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
The use of Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions (5.11), Description (11)].

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA204275
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
05-23-2022
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 66993-135-97 identifies a specific commercial package of 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler of Fluticasone Furoate And Vilanterol, a human prescription drug labeled by Prasco Laboratories. This powder is formulated for respiratory (inhalation) use and contains fluticasone furoate; 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 May 23, 2022. The current certification is valid through December 31, 2027.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993013597. 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)
66993-135-97
11-Digit CMS (5-4-2)
66993-0135-97

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