Pramosone Ointment
NDC Package 83107-014-01

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

Package Information

Pramosone (hydrocortisone acetate and pramoxine hydrochloride) ointment is pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. This formulation utilizes a ointment delivery system. Marketed by Legacy Pharma Usa Inc, this product is identified by NDC 83107-014.

Identification & Billing

NDC Package Code
83107-014-01
Package Description
28.4 g in 1 TUBE
Product Code
83107-014
11-Digit Billing Format
83107001401
RxNorm Crosswalk
  • RxCUI: 1234333 - hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical Ointment
  • RxCUI: 1234333 - hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment
  • RxCUI: 1234333 - hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical Ointment
  • RxCUI: 1234338 - Pramosone 2.5 % / 1 % Topical Ointment
  • RxCUI: 1234338 - hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]

Clinical Specifications

Proprietary Name
Pramosone
Non-Proprietary Name
Hydrocortisone Acetate And Pramoxine Hydrochloride
Substance Name
Hydrocortisone Acetate; Pramoxine Hydrochloride
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)
Pharmacologic Class
Usage Information
Pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. Hydrocortisone is a corticosteroid that reduces redness, swelling, and itching. This combination medication is used to treat certain skin conditions such as eczema, rash, scrapes, insect bites, or minor burns. This combination product for the skin is available in different strengths and forms (e.g., creams, ointments, and lotions). The type of medication used depends on the location of your condition and the type of skin problem being treated. Creams are the most frequently used form. Lotions may be better suited to hairy areas. Ointments may be better suited for dry areas and when a stronger effect or skin protection is desired.

Regulatory & Marketing

Labeler Name
Legacy Pharma Usa Inc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
03-18-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83107-014-01 identifies a specific commercial package of 28.4 g in 1 tube of Pramosone, a human prescription drug labeled by Legacy Pharma Usa Inc. This ointment is formulated for topical use and contains hydrocortisone acetate; pramoxine hydrochloride 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 Legacy Pharma Usa Inc on March 18, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. Hydrocortisone is a corticosteroid that reduces redness, swelling, and itching. This combination medication is used to treat certain skin conditions such as eczema, rash, scrapes, insect bites, or minor burns. This combination product for the skin is available in different strengths and forms (e.g., creams, ointments, and lotions). The type of medication used depends on the location of your condition and the type of skin problem being treated. Creams are the most frequently used form. Lotions may be better suited to hairy areas. Ointments may be better suited for dry areas and when a stronger effect or skin protection is desired.

How is this Legacy Pharma Usa Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83107001401. 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)
83107-014-01
11-Digit CMS (5-4-2)
83107-0014-01

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