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  5. NDC Package Code: 59651-585-30 Budesonide

NDC Package 59651-585-30 Budesonide

Suspension Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
59651-585-30
Package Description:
6 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE
Product Code:
59651-585
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:
59651058530
NDC to RxNorm Crosswalk:
  • RxCUI: 351109 - budesonide 0.5 MG in 2 ML Inhalation Suspension
  • RxCUI: 351109 - budesonide 0.25 MG/ML Inhalation Suspension
  • RxCUI: 351109 - budesonide 0.5 MG per 2 ML Inhalation Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • BUDESONIDE .5 mg/2mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216667
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-29-2023
    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.

    Frequently Asked Questions

    What is NDC 59651-585-30?

    The NDC Packaged Code 59651-585-30 is assigned to a package of 6 pouch in 1 carton / 5 ampule in 1 pouch (59651-585-05) / 2 ml in 1 ampule of Budesonide, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is suspension and is administered via respiratory (inhalation) form.

    Is NDC 59651-585 included in the NDC Directory?

    Yes, Budesonide with product code 59651-585 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on November 29, 2023 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 59651-585-30?

    The 11-digit format is 59651058530. 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 5-3-2 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
    5-3-259651-585-305-4-259651-0585-30