Pulmicort
NDC Package 54868-5844-0

11-digit billing NDC: 54868584400 · Billing unit: EA · 1 EA per package
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.

Pulmicort is fLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5844 and is authorized under FDA application NDA021949.

Identification & Billing

NDC Package Code
54868-5844-0
Package Description
1 INHALER in 1 CARTON / 120 AEROSOL, POWDER in 1 INHALER
Product Code
54868-5844
11-Digit Billing Format
54868584400
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: 966522 - budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT
  • RxCUI: 966522 - 120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 966522 - budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT
  • RxCUI: 966522 - budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS
  • RxCUI: 966524 - Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT

Clinical Specifications

Proprietary Name
Pulmicort Flexhaler
Dosage Form
-
Usage Information
PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Important Limitations of Use:PULMICORT FLEXHALER is NOT indicated for the relief of acute bronchospasm.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021949
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-28-2007
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 54868-5844-0 identifies a specific commercial package of 1 inhaler in 1 carton / 120 aerosol, powder in 1 inhaler of Pulmicort Flexhaler, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 December 28, 2007. 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: 54868584400. 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 (5-4-1)
54868-5844-0
11-Digit CMS (5-4-2)
54868-5844-00

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