Fluticasone Propionate And Salmeterol Powder
NDC Package 69097-661-03

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)]. This formulation utilizes a powder delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-661 and is authorized under FDA application ANDA213087.

Identification & Billing

NDC Package Code
69097-661-03
Package Description
1 INHALER in 1 CARTON / 60 POWDER in 1 INHALER
Product Code
69097-661
11-Digit Billing Format
69097066103

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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213087
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-27-2026
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 69097-661-03 identifies a specific commercial package of 1 inhaler in 1 carton / 60 powder in 1 inhaler of Fluticasone Propionate And Salmeterol, a human prescription drug labeled by Cipla 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 Cipla Usa Inc. on July 27, 2026. The current certification is valid through December 31, 2027.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097066103. 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)
69097-661-03
11-Digit CMS (5-4-2)
69097-0661-03

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