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  5. NDC Package Code: 54868-5621-0 Pulmicort Respules

NDC Package 54868-5621-0 Pulmicort Respules

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
54868-5621-0
Package Description:
6 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
Product Code:
54868-5621
Proprietary Name:
Pulmicort Respules
Usage Information:
PULMICORT RESPULES should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of PULMICORT RESPULES and, therefore, are NOT recommended. The effects of mixing PULMICORT RESPULES with other nebulizable medications have not been adequately assessed. PULMICORT RESPULES should be administered separately in the nebulizer [see Patient Counseling Information, Administration with a jet nebulizer (17.1)]. A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver PULMICORT RESPULES to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of PULMICORT RESPULES delivered by other nebulizers and compressors have not been established.
11-Digit NDC Billing Format:
54868562100
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 349094 - budesonide 0.25 MG in 2 ML Inhalation Suspension
  • RxCUI: 349094 - budesonide 0.125 MG/ML Inhalation Suspension
  • RxCUI: 349094 - budesonide 0.25 MG per 2 ML Inhalation Suspension
  • RxCUI: 351109 - budesonide 0.5 MG in 2 ML Inhalation Suspension
  • RxCUI: 351109 - budesonide 0.25 MG/ML Inhalation Suspension
    • Labeler Name:
    Physicians Total Care, Inc.
    Sample Package:
    No
    Start Marketing Date:
    06-29-2006
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 54868-5621-0?

    The NDC Packaged Code 54868-5621-0 is assigned to a package of 6 pouch in 1 carton / 5 ampule in 1 pouch / 2 ml in 1 ampule of Pulmicort Respules, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.

    Is NDC 54868-5621 included in the NDC Directory?

    No, Pulmicort Respules with product code 54868-5621 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on June 29, 2006 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54868-5621-0?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 54868-5621-0?

    The 11-digit format is 54868562100. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-154868-5621-05-4-254868-5621-00