Pramosone Lotion
NDC Package 83107-021-04

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

Pramosone (hydrocortisone acetate and pramoxine hydrochloride) lotions is pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. This formulation utilizes a lotion delivery system. Marketed by Legacy Pharma Usa Inc., this product is identified by NDC 83107-021 and is authorized under FDA application ANDA085979.

Identification & Billing

NDC Package Code
83107-021-04
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
83107-021
11-Digit Billing Format
83107002104
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk
  • RxCUI: 1234512 - hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal Lotion
  • RxCUI: 1234512 - hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
  • RxCUI: 1234512 - hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal Lotion
  • RxCUI: 1234514 - Pramosone 2.5 % / 1 % Topical Lotion
  • RxCUI: 1234514 - hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]

Clinical Specifications

Proprietary Name
Pramosone
Non-Proprietary Name
Hydrocortisone Acetate And Pramoxine Hydrochloride
Substance Name
Hydrocortisone Acetate; Pramoxine Hydrochloride
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)
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
FDA Application #
ANDA085979
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-27-2025
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 (83107-021). Click a package code to view its specific billing and regulatory data.

83107-021-02
59 mL in 1 BOTTLE, PLASTIC

* 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 83107-021-04 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Pramosone, a human prescription drug labeled by Legacy Pharma Usa Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. This lotion 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 May 27, 2025. The current certification is valid through December 31, 2026.

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: 83107002104. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
83107-021-04
11-Digit CMS (5-4-2)
83107-0021-04

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