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  5. NDC Package Code: 83107-022-04 Pramosone

NDC Package 83107-022-04 Pramosone

Hydrocortisone Acetate And Pramoxine Hydrochloride Lotion Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83107-022-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
83107-022
Proprietary Name:
Pramosone
Non-Proprietary Name:
Hydrocortisone Acetate And Pramoxine Hydrochloride
Substance Name:
Hydrocortisone Acetate; Pramoxine Hydrochloride
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.
11-Digit NDC Billing Format:
83107002204
NDC to RxNorm Crosswalk:
  • RxCUI: 1234393 - hydrocortisone acetate 1 % / pramoxine HCl 1 % Topical Lotion
  • RxCUI: 1234393 - hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
  • RxCUI: 1234393 - hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Topical Lotion
  • RxCUI: 1234396 - Pramosone 1 % / 1 % Topical Lotion
  • RxCUI: 1234396 - hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]
Product Type:
Human Prescription Drug
Labeler Name:
Legacy Pharma Usa Inc.
Dosage Form:
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route(s):
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(es):
Sample Package:
No
FDA Application Number:
ANDA085980
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-06-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 83107-022-04?

The NDC Packaged Code 83107-022-04 is assigned to a package of 118 ml in 1 bottle of Pramosone, a human prescription drug labeled by Legacy Pharma Usa Inc.. The product's dosage form is lotion and is administered via topical form.

Is NDC 83107-022 included in the NDC Directory?

Yes, Pramosone with product code 83107-022 is active and included in the NDC Directory. The product was first marketed by Legacy Pharma Usa Inc. on June 06, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 83107-022-04?

The 11-digit format is 83107002204. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-283107-022-045-4-283107-0022-04