Hydrocortisone Butyrate Ointment
NDC Package 51672-4083-2

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 ointment is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a ointment delivery system. Marketed by Taro Pharmaceuticals U.s.a., Inc., this product is identified by NDC 51672-4083 and is authorized under FDA application ANDA076842.

Identification & Billing

NDC Package Code
51672-4083-2
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
51672-4083
11-Digit Billing Format
51672408302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydrocortisone Butyrate
Non-Proprietary Name
Hydrocortisone Butyrate
Substance Name
Hydrocortisone Butyrate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 BUTYRATE 1 mg/g
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
Taro Pharmaceuticals U.s.a., Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076842
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2004
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 (51672-4083). Click a package code to view its specific billing and regulatory data.

51672-4083-1
1 TUBE in 1 CARTON / 15 g in 1 TUBE
51672-4083-5
5 g in 1 TUBE
51672-4083-6
1 TUBE in 1 CARTON / 45 g in 1 TUBE
51672-4083-7
1 TUBE in 1 CARTON / 10 g in 1 TUBE

* 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 51672-4083-2 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Hydrocortisone Butyrate, a human prescription drug labeled by Taro Pharmaceuticals U.s.a., Inc.. This ointment 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 Taro Pharmaceuticals U.s.a., Inc. on December 27, 2004. 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 Taro Pharmaceuticals U.s.a., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672408302. 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 (5-4-1)
51672-4083-2
11-Digit CMS (5-4-2)
51672-4083-02

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