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  5. NDC Package Code: 0536-1112-40 Budesonide

NDC Package 0536-1112-40 Budesonide

Spray, Metered Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
0536-1112-40
Package Description:
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code:
0536-1112
Proprietary Name:
Budesonide
Non-Proprietary Name:
Budesonide
Substance Name:
Budesonide
Usage Information:
Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.
11-Digit NDC Billing Format:
00536111240
NDC to RxNorm Crosswalk:
  • RxCUI: 1797929 - budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797929 - budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rugby Laboratories
    Dosage Form:
    Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • BUDESONIDE 32 ug/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078949
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-13-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0536-1112-481 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0536-1112-40?

    The NDC Packaged Code 0536-1112-40 is assigned to a package of 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray of Budesonide, a human over the counter drug labeled by Rugby Laboratories. The product's dosage form is spray, metered and is administered via nasal form.

    Is NDC 0536-1112 included in the NDC Directory?

    Yes, Budesonide with product code 0536-1112 is active and included in the NDC Directory. The product was first marketed by Rugby Laboratories on July 13, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0536-1112-40?

    The 11-digit format is 00536111240. 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 4-4-2 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
    4-4-20536-1112-405-4-200536-1112-40