Truelipids 1% Hydrocortisone Barrier Cream
NDC Package 61387-252-01

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

Package Information

Truelipids 1% Hydrocortisone Barrier Cream (hydrocortisone) cream is a medication used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). This formulation utilizes a cream delivery system. Marketed by Claridei Laboratories, this product is identified by NDC 61387-252 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
61387-252-01
Package Description
50 g in 1 TUBE
Product Code
61387-252
11-Digit Billing Format
61387025201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Truelipids 1% Hydrocortisone Barrier Cream
Non-Proprietary Name
Hydrocortisone
Substance Name
Hydrocortisone
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 1 g/100g
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

Regulatory & Marketing

Labeler Name
Claridei Laboratories
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-10-2023
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 61387-252-01 identifies a specific commercial package of 50 g in 1 tube of Truelipids 1% Hydrocortisone Barrier Cream, a human over the counter drug labeled by Claridei Laboratories. This cream is formulated for topical use and contains hydrocortisone 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 Claridei Laboratories on August 10, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

How is this Claridei Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61387025201. 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)
61387-252-01
11-Digit CMS (5-4-2)
61387-0252-01

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