Fluticasone Propionate And Salmeterol Hfa Aerosol, Metered
NDC Package 66993-088-96

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

Package Information

Fluticasone Propionate And Salmeterol Hfa (fluticasone propionate and salmeterol xinafoate) aerosols is fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. This formulation utilizes a aerosol, metered delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-088 and is authorized under FDA application NDA021254.

Identification & Billing

NDC Package Code
66993-088-96
Package Description
1 INHALER in 1 CARTON / 120 AEROSOL, METERED in 1 INHALER
Product Code
66993-088
11-Digit Billing Format
66993008896
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 896236 - fluticasone propionate/salmeterol 45/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 896236 - 120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 896236 - fluticasone propionate 0.045 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 896236 - fluticasone propionate 45 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 896244 - fluticasone propionate/salmeterol 115/21 MCG/INHAL Metered Dose Inhaler, 120 Actuations

Clinical Specifications

Proprietary Name
Fluticasone Propionate And Salmeterol Hfa
Non-Proprietary Name
Fluticasone Propionate And Salmeterol Xinafoate
Substance Name
Fluticasone Propionate; Salmeterol Xinafoate
Dosage Form
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
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
Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).Limitations of UseFluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm.

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA021254
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
03-01-2023
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 66993-088-96 identifies a specific commercial package of 1 inhaler in 1 carton / 120 aerosol, metered in 1 inhaler of Fluticasone Propionate And Salmeterol Hfa, a human prescription drug labeled by Prasco Laboratories. This aerosol, metered is formulated for respiratory (inhalation) use and contains fluticasone propionate; salmeterol xinafoate 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 March 01, 2023. 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: 66993008896. 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)
66993-088-96
11-Digit CMS (5-4-2)
66993-0088-96

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