Hydrocortisone Butyrate
NDC Package 51862-159-04

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 discontinued by the firm.

Hydrocortisone Butyrate is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Marketed by Mayne Pharma Commercial Llc, this product is identified by NDC 51862-159 and is authorized under FDA application ANDA209556.

Identification & Billing

NDC Package Code
51862-159-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
51862-159
11-Digit Billing Format
51862015904
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Hydrocortisone Butyrate
Dosage Form
-
Usage Information
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Hydrocortisone butyrate reduces the swelling, itching, and redness that can occur in these types of conditions. The topical solution is used to treat severe dandruff (seborrheic dermatitis). This medication is a medium-strength corticosteroid.

Regulatory & Marketing

Labeler Name
Mayne Pharma Commercial Llc
FDA Application #
ANDA209556
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2019
End Marketing Date
02-08-2022
Listing Expiration
02-08-2022
Exclude Flag
D
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 51862-159-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Hydrocortisone Butyrate, labeled by Mayne Pharma Commercial Llc. 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 Mayne Pharma Commercial Llc on November 29, 2019. The current certification is valid through February 08, 2022.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Hydrocortisone butyrate reduces the swelling, itching, and redness that can occur in these types of conditions. The topical solution is used to treat severe dandruff (seborrheic dermatitis). This medication is a medium-strength corticosteroid.

How is this Mayne Pharma Commercial Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862015904. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
51862-159-04
11-Digit CMS (5-4-2)
51862-0159-04

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