Careall Hydrocortisone Cream
NDC Package 51824-050-01

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

Careall Hydrocortisone (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 New World Imports, Inc, this product is identified by NDC 51824-050 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
51824-050-01
Package Description
28 g in 1 TUBE
Product Code
51824-050
11-Digit Billing Format
51824005001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28 GM

Clinical Specifications

Proprietary Name
Careall Hydrocortisone Maximum Strength
Non-Proprietary Name
Hydrocortisone
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 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
New World Imports, Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-11-2016
End Marketing Date
01-01-2027
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 (51824-050). Click a package code to view its specific billing and regulatory data.

51824-050-14
144 PACKET in 1 CONTAINER / .9 g in 1 PACKET (51824-050-09)

* 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 51824-050-01 identifies a specific commercial package of 28 g in 1 tube of Careall Hydrocortisone Maximum Strength, a human over the counter drug labeled by New World Imports, Inc. This product is billed per "GM" gram and contains an estimated amount of 28 billable units per package. 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 New World Imports, Inc on March 11, 2016.

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 New World Imports, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51824005001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28 total billable units per package. 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)
51824-050-01
11-Digit CMS (5-4-2)
51824-0050-01

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