Fluticasone
NDC Package 61919-004-16

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fluticasone is propionate Nasal Spray, USP is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older.Safety and effectiveness of Fluticasone Propionate Nasal Spray, USP in children below 4 years of age have not been adequately established. Marketed by Direct Rx, this product is identified by NDC 61919-004 and is authorized under FDA application ANDA078492.

Identification & Billing

NDC Package Code
61919-004-16
Package Description
1 SPRAY, METERED in 1 BOX
Product Code
61919-004
11-Digit Billing Format
61919000416
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1797907 - fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797907 - fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Fluticasone
Dosage Form
-
Usage Information
Fluticasone Propionate Nasal Spray, USP is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older.Safety and effectiveness of Fluticasone Propionate Nasal Spray, USP in children below 4 years of age have not been adequately established.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA078492
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2014
Listing Expiration
12-31-2024
Exclude Flag
I
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 61919-004-16 identifies a specific commercial package of 1 spray, metered in 1 box of Fluticasone, labeled by Direct Rx. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Direct Rx on January 01, 2014. The current certification is valid through December 31, 2024.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919000416. 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)
61919-004-16
11-Digit CMS (5-4-2)
61919-0004-16

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