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  5. NDC Package Code: 68382-720-16 Budesonide

NDC Package 68382-720-16 Budesonide

Capsule, Coated Pellets Oral - 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:
68382-720-16
Package Description:
90 CAPSULE, COATED PELLETS in 1 BOTTLE
Product Code:
68382-720
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:
68382072016
NDC to RxNorm Crosswalk:
  • RxCUI: 1244214 - budesonide 3 MG Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa Inc.
    Dosage Form:
    Capsule, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BUDESONIDE 3 mg/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA206134
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-08-2017
    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
    68382-720-01100 CAPSULE, COATED PELLETS in 1 BOTTLE
    68382-720-05500 CAPSULE, COATED PELLETS in 1 BOTTLE
    68382-720-0630 CAPSULE, COATED PELLETS in 1 BOTTLE
    68382-720-101000 CAPSULE, COATED PELLETS in 1 BOTTLE
    68382-720-7710 BLISTER PACK in 1 CARTON / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68382-720-16?

    The NDC Packaged Code 68382-720-16 is assigned to a package of 90 capsule, coated pellets in 1 bottle of Budesonide, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is capsule, coated pellets and is administered via oral form.

    Is NDC 68382-720 included in the NDC Directory?

    Yes, Budesonide with product code 68382-720 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on June 08, 2017 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 68382-720-16?

    The 11-digit format is 68382072016. 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
    5-3-268382-720-165-4-268382-0720-16