Fluticasone Propionate And Salmeterol Powder
NDC Package 0093-7516-31

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 the use of fluticasone propionate and salmeterol inhalation powder is contraindicated in the following conditions:Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2)].Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions (5.11), Adverse Reactions (6.3), Description (11)]. This formulation utilizes a powder delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-7516 and is authorized under FDA application ANDA213948.

Identification & Billing

NDC Package Code
0093-7516-31
Package Description
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
Product Code
0093-7516
11-Digit Billing Format
00093751631
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: 896184 - fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters
  • RxCUI: 896184 - 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 896184 - fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 896184 - fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 896209 - fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters

Clinical Specifications

Proprietary Name
Fluticasone Propionate And Salmeterol
Non-Proprietary Name
Fluticasone Propionate And Salmeterol
Substance Name
Fluticasone Propionate; Salmeterol Xinafoate
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 propionate and salmeterol inhalation powder is contraindicated in the following conditions:Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2)].Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions (5.11), Adverse Reactions (6.3), Description (11)].

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213948
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-23-2022
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 0093-7516-31 identifies a specific commercial package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder in 1 inhaler of Fluticasone Propionate And Salmeterol, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This powder 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 March 23, 2022. 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: 00093751631. 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)
0093-7516-31
11-Digit CMS (5-4-2)
00093-7516-31

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