Hydrocortisone Acetate
NDC 72056-010

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72056-010?
  5. Hydrocortisone Acetate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hydrocortisone Acetate is a UNAPPROVED DRUG OTHER-approved product labeled by Syntenza Pharmaceuticals Llc. This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is supplied as a white product. This product entry covers the primary NDC 72056-010 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
72056-010
Proprietary Name:
Hydrocortisone Acetate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Syntenza Pharmaceuticals Llc
Labeler Code:
72056
Product Label ID:
883ff13e-1717-402d-8410-79a5e72550eb
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
06-20-2018
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
BULLET (C48335)
Score:
1

Code Structure Chart

Product Details

What is NDC 72056-010?

The NDC code 72056-010 is assigned by the FDA to the product Hydrocortisone Acetate. This pharmaceutical product is labeled by Syntenza Pharmaceuticals Llc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 72056-010-12, 72056-010-24. 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?

This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.

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:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

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

Patient Education

Hydrocortisone Rectal


Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
[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 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 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".