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  5. NDC Package Code: 54766-729-04 Pramosone

NDC Package 54766-729-04 Pramosone

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
54766-729-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
54766-729
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:
54766072904
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
118 ML
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 (hydrocortisone acetate 1 % / pramoxine HCl 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:
    Sebela Pharmaceuticals 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):
  • HYDROCORTISONE ACETATE 10 mg/mL
  • PRAMOXINE HYDROCHLORIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA085980
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-02-2015
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    54766-729-0659 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54766-729-04?

    The NDC Packaged Code 54766-729-04 is assigned to a package of 118 ml in 1 bottle of Pramosone, a human prescription drug labeled by Sebela Pharmaceuticals Inc.. The product's dosage form is lotion and is administered via topical form.This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package.

    Is NDC 54766-729 included in the NDC Directory?

    Yes, Pramosone with product code 54766-729 is active and included in the NDC Directory. The product was first marketed by Sebela Pharmaceuticals Inc. on July 02, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54766-729-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 118.

    What is the 11-digit format for NDC 54766-729-04?

    The 11-digit format is 54766072904. 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
    5-3-254766-729-045-4-254766-0729-04