Astelin
NDC Package 54868-5072-0

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.

Astelin is ® Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5072 and is authorized under FDA application NDA020114.

Identification & Billing

NDC Package Code
54868-5072-0
Package Description
1 BOTTLE, SPRAY in 1 BOX / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
54868-5072
11-Digit Billing Format
54868507200
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1797867 - azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797867 - azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797876 - Astelin 137 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797876 - azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray [Astelin]
  • RxCUI: 1797876 - Astelin 0.137 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Astelin
Dosage Form
-
Usage Information
Astelin® Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020114
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-25-2004
Listing Expiration
12-31-2017
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 54868-5072-0 identifies a specific commercial package of 1 bottle, spray in 1 box / 200 spray, metered in 1 bottle, spray of Astelin, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on May 25, 2004. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868507200. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
54868-5072-0
11-Digit CMS (5-4-2)
54868-5072-00

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