Hydrocortisone Butyrate Lotion
NDC Package 83148-012-04

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

Hydrocortisone Butyrate lotions is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a lotion delivery system. Marketed by The J. Molner Company Llc, this product is identified by NDC 83148-012 and is authorized under FDA application ANDA209556.

Identification & Billing

NDC Package Code
83148-012-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
83148-012
11-Digit Billing Format
83148001204
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydrocortisone Butyrate
Non-Proprietary Name
Hydrocortisone Butyrate
Substance Name
Hydrocortisone Butyrate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 BUTYRATE 1 mg/mL
Pharmacologic Class
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
The J. Molner Company Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209556
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-06-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83148-012). Click a package code to view its specific billing and regulatory data.

83148-012-02
1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE

* 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 83148-012-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Hydrocortisone Butyrate, a human prescription drug labeled by The J. Molner Company Llc. This lotion is formulated for topical use and contains hydrocortisone butyrate 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 The J. Molner Company Llc on November 06, 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., 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 The J. Molner Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83148001204. 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)
83148-012-04
11-Digit CMS (5-4-2)
83148-0012-04

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