Pramosone Lotion
NDC 54766-729

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 54766-729?
  4. Pramosone Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Pramosone (hydrocortisone acetate and pramoxine hydrochloride) is a ANDA-approved product labeled by Sebela Pharmaceuticals Inc.. Pramoxine is an anesthetic used on the skin to relieve minor pain, itching, and discomfort. It is supplied as a lotion for topical administration. This product entry covers the primary NDC 54766-729 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54766-729
Proprietary Name:
Pramosone
Non-Proprietary Name: [1]
Hydrocortisone Acetate And Pramoxine Hydrochloride
Substance Name: [2]
Hydrocortisone Acetate; Pramoxine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Sebela Pharmaceuticals Inc.
Labeler Code:
54766
Product Label ID:
f207bdff-2f41-4eee-818e-198b6462863e
FDA Application Number: [6]
ANDA085980
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-02-2015
End Marketing Date: [10]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 54766-729?

The NDC code 54766-729 is assigned by the FDA to the product Pramosone. It is commonly known by its generic name, hydrocortisone acetate and pramoxine hydrochloride. This pharmaceutical product is labeled by Sebela Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a lotion administered via topical route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 54766-729-03, 54766-729-04, 54766-729-06. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Hydrocortisone Topical


Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
[Learn More]


Pramoxine


Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".