Fluticasone Propionate And Salmeterol Powder, Metered
NDC Package 0093-3607-82

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 powders is fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in patients aged 12 years and older. This formulation utilizes a powder, metered delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-3607 and is authorized under FDA application NDA208799.

Identification & Billing

NDC Package Code
0093-3607-82
Package Description
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
Product Code
0093-3607
11-Digit Billing Format
00093360782
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: 1918194 - fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 1918194 - 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1918194 - fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS
  • RxCUI: 1918203 - fluticasone propionate/salmeterol 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 1918203 - 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler

Clinical Specifications

Proprietary Name
Fluticasone Propionate And Salmeterol
Non-Proprietary Name
Fluticasone Propionate And Salmeterol
Substance Name
Fluticasone Propionate; Salmeterol Xinafoate
Dosage Form
Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.
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/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2 adrenergic agonist (LABA).Limitations of Use:Fluticasone Propionate/Salmeterol MDPI is NOT indicated for the relief of acute bronchospasm.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208799
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
04-28-2017
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 0093-3607-82 identifies a specific commercial package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder, metered in 1 inhaler of Fluticasone Propionate And Salmeterol, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This powder, 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 Teva Pharmaceuticals Usa, Inc. on April 28, 2017. The current certification is valid through December 31, 2026.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093360782. 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 (4-4-2)
0093-3607-82
11-Digit CMS (5-4-2)
00093-3607-82

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