Budesonide (enteric Coated)
NDC 51407-128

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51407-128?
  5. Budesonide (enteric Coated) Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Budesonide (enteric Coated) is a ANDA-approved product labeled by Golden State Medical Supply, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a pink product. This product entry covers the primary NDC 51407-128 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
51407-128
Proprietary Name:
Budesonide (enteric Coated)
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Golden State Medical Supply, Inc.
Labeler Code:
51407
Product Label ID:
c5d97b04-e206-4325-e053-2a95a90ab610
FDA Application Number: [6]
ANDA206623
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-08-2016
End Marketing Date: [10]
03-31-2026
Listing Expiration Date: [11]
03-31-2026
Exclude Flag: [12]
D

Product Characteristics

Color(s):
PINK (C48328 - PINK OPAQUE CAP)
WHITE (C48325 - WHITE OPAQUE BODY)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
M580
Score:
1

Code Structure Chart

Product Details

What is NDC 51407-128?

The NDC code 51407-128 is assigned by the FDA to the product Budesonide (enteric Coated). This pharmaceutical product is labeled by Golden State Medical Supply, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 51407-128-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred [see Adverse Reactions (6.2)] .

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

* Please review the full disclaimer at the bottom of this page.

Patient Education

Budesonide


Budesonide (Entocort EC) is used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Budesonide (Tarpeyo) is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation). Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn's disease or in the kidney of people with nephropathy.
[Learn More]


Steroids


You may have heard of anabolic steroids, which can have harmful effects. But there's another type of steroid - sometimes called a corticosteroid - that treats a variety of problems. These steroids are similar to hormones that your adrenal glands make to fight stress associated with illnesses and injuries. They reduce inflammation and affect the immune system.

You may need to take corticosteroids to treat:

  • Arthritis
  • Asthma
  • Autoimmune diseases such as lupus and multiple sclerosis
  • Skin conditions such as eczema and rashes
  • Some kinds of cancer

Steroids are strong medicines, and they can have side effects, including weakened bones and cataracts. Because of this, you usually take them for as short a time as possible.


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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".