Claravie Cream
NDC Package 61554-311-21

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

Package Information

Claravie (hydrocortisone acetate) 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 Gentell Llc, this product is identified by NDC 61554-311 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
61554-311-21
Package Description
.9 g in 1 PACKET
Product Code
61554-311
11-Digit Billing Format
61554031121

Clinical Specifications

Proprietary Name
Claravie
Non-Proprietary Name
Hydrocortisone Acetate
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/100g
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
Gentell Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-21-2026
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61554-311). Click a package code to view its specific billing and regulatory data.

61554-311-11
28.3 g in 1 TUBE
61554-311-31
454 g in 1 JAR

* 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 61554-311-21 identifies a specific commercial package of .9 g in 1 packet of Claravie, a human over the counter drug labeled by Gentell Llc. 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 Gentell Llc on August 21, 2026. The current certification is valid through December 31, 2027.

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 Gentell Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61554031121. 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)
61554-311-21
11-Digit CMS (5-4-2)
61554-0311-21

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