Sionbiotext Hydrocortisone Cream
NDC Package 68786-001-28

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

Package Information

Sionbiotext Hydrocortisone (hydrocortisone acetate 1%) cream is a medication used to treat hemorrhoids and itching/swelling in the rectum and anus. This formulation utilizes a cream delivery system. Marketed by Sion Biotext Medical Ltd, this product is identified by NDC 68786-001 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
68786-001-28
Package Description
28.3 g in 1 BOX
Product Code
68786-001
11-Digit Billing Format
68786000128

Clinical Specifications

Proprietary Name
Sionbiotext Hydrocortisone
Non-Proprietary Name
Hydrocortisone Acetate 1%
Substance Name
Hydrocortisone Acetate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
HYDROCORTISONE ACETATE .1 g/g
Pharmacologic Class
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
Sion Biotext Medical Ltd
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-13-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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 68786-001-28 identifies a specific commercial package of 28.3 g in 1 box of Sionbiotext Hydrocortisone, a human over the counter drug labeled by Sion Biotext Medical Ltd. This cream is formulated for topical use and contains hydrocortisone acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sion Biotext Medical Ltd on May 13, 2025. The current certification is valid through December 31, 2026.

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 Sion Biotext Medical Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68786000128. 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)
68786-001-28
11-Digit CMS (5-4-2)
68786-0001-28

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