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  5. NDC Package Code: 68682-658-03 Budesonide

NDC Package 68682-658-03 Budesonide

Aerosol, Foam Rectal - 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:
68682-658-03
Package Description:
2 CANISTER in 1 CARTON / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)
Product Code:
68682-658
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:
68682065803
NDC to RxNorm Crosswalk:
  • RxCUI: 1596779 - budesonide 2 MG/ACTUAT Rectal Foam, 14 ACTUAT
  • RxCUI: 1596779 - 14 ACTUAT budesonide 2 MG/ACTUAT Rectal Foam
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Oceanside Pharmaceuticals
    Dosage Form:
    Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
    Administration Route(s):
  • Rectal - Administration to the rectum.
    • Active Ingredient(s):
  • BUDESONIDE 28 mg/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA205613
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-15-2022
    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 68682-658-03?

    The NDC Packaged Code 68682-658-03 is assigned to a package of 2 canister in 1 carton / 1 aerosol, foam in 1 canister (68682-658-02) of Budesonide, a human prescription drug labeled by Oceanside Pharmaceuticals. The product's dosage form is aerosol, foam and is administered via rectal form.

    Is NDC 68682-658 included in the NDC Directory?

    Yes, Budesonide with product code 68682-658 is active and included in the NDC Directory. The product was first marketed by Oceanside Pharmaceuticals on July 15, 2022 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 68682-658-03?

    The 11-digit format is 68682065803. 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
    5-3-268682-658-035-4-268682-0658-03