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  4. NDC Product Code: 0781-2072 Budesonide

NDC 0781-2072 Budesonide

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0781-2072?
  5. Budesonide Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This code was recently added to the official NDC directory and the product has entered commercial distribution.
This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 0781-2072 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0781-2072
Proprietary Name:
Budesonide
Product Type: [3]
Labeler Name: [5]
Sandoz Inc
Labeler Code:
0781
Product Label ID:
95b6b7a2-50f8-40c7-a683-b7eaf78efb34
FDA Application Number: [6]
ANDA209041
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
06-27-2025
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - (SWEDISH-ORANGE))
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
SC2091
Score:
1

Code Structure Chart

Product Details

What is NDC 0781-2072?

The NDC code 0781-2072 is assigned by the FDA to the product Budesonide which is product labeled by Sandoz Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 0781-2072-01 100 capsule in 1 bottle , 0781-2072-05 500 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Budesonide?

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.

Which are Budesonide UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Budesonide Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".