NDC Compounded Drug 79926-019-10 Budesonide

Tablet Oral

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 79926-019
NDC Package Code 79926-019-10
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 79926001910
Package Description 100 TABLET in 1 BOTTLE, PLASTIC
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Budesonide
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 Budesonide
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 Budesonide
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 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.
Dosage Form Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Route Name Oral - Administration to or by way of the mouth.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 79926
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Wedgewood Connect, Llc
Substance Name Budesonide
Active Ingredients Information 1 mg
Reporting Period 2021-2

Frequently Asked Questions

What is the NDC number assigned to Budesonide?

Budesonide was assigned by its manufacturer with NDC product code 79926-019. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Budesonide?

The NDC package code 79926-019-10 was assigned to a 100 TABLET in 1 BOTTLE, PLASTIC of budesonide administered oral via tablet.

Who manufactures this product?

Budesonide is manufactured by an outsourced facility and labeled by Wedgewood Connect, Llc. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.