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  5. NDC Package Code: 0378-4500-93 Budesonide

NDC Package 0378-4500-93 Budesonide

Tablet, Film Coated, Extended Release Oral - 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:
0378-4500-93
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
0378-4500
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:
00378450093
NDC to RxNorm Crosswalk:
  • RxCUI: 1366550 - budesonide 9 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1366550 - 24 HR budesonide 9 MG Extended Release Oral Tablet
  • RxCUI: 1366550 - budesonide 9 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BUDESONIDE 9 mg/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208851
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-20-2020
    End Marketing Date:
    04-30-2024
    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 0378-4500-93?

    The NDC Packaged Code 0378-4500-93 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle, plastic of Budesonide, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0378-4500 included in the NDC Directory?

    Yes, Budesonide with product code 0378-4500 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on October 20, 2020.

    What is the 11-digit format for NDC 0378-4500-93?

    The 11-digit format is 00378450093. 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
    4-4-20378-4500-935-4-200378-4500-93