Hydrocortisone Acetate
NDC Package 50382-007-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Hydrocortisone Acetate is a medication used to treat hemorrhoids and itching/swelling in the rectum and anus. Marketed by Galentic Pharma (india) Private Limited, this product is identified by NDC 50382-007 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
50382-007-01
Package Description
28.4 g in 1 TUBE
Product Code
50382-007
11-Digit Billing Format
50382000701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydrocortisone Acetate
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Galentic Pharma (india) Private Limited
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
09-06-2011
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50382-007-01 identifies a specific commercial package of 28.4 g in 1 tube of Hydrocortisone Acetate, labeled by Galentic Pharma (india) Private Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Galentic Pharma (india) Private Limited on September 06, 2011. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

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.

How is this Galentic Pharma (india) Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50382000701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50382-007-01
11-Digit CMS (5-4-2)
50382-0007-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.