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  4. NDC Product Code: 54766-799 Analpram Hc

NDC 54766-799 Analpram Hc

Hydrocortisone Acetate And Pramoxine Hydrochloride Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54766-799?
  4. Analpram Hc 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

NDC Product Code:
54766-799
Proprietary Name:
Analpram Hc
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
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 Name: [5]
    Sebela Pharmaceuticals Inc.
    Labeler Code:
    54766
    Product Label ID:
    fecf8380-3bb5-11e5-98c5-0002a5d5c51b
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    08-07-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 54766-799-04

    Package Description: 28.4 g in 1 TUBE, WITH APPLICATOR

    NDC Code 54766-799-64

    Package Description: 30 TUBE, WITH APPLICATOR in 1 CARTON / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36)

    NDC Code 54766-799-65

    Package Description: 12 TUBE, WITH APPLICATOR in 1 CARTON / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36)

    NDC Code 54766-799-71

    Package Description: 30 TUBE, WITH APPLICATOR in 1 CARTON / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33)

    NDC Code 54766-799-72

    Package Description: 12 TUBE, WITH APPLICATOR in 1 CARTON / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33)

    Product Details

    What is NDC 54766-799?

    The NDC code 54766-799 is assigned by the FDA to the product Analpram Hc which is a human prescription drug product labeled by Sebela Pharmaceuticals Inc.. The generic name of Analpram Hc is hydrocortisone acetate and pramoxine hydrochloride. The product's dosage form is cream and is administered via topical form. The product is distributed in 5 packages with assigned NDC codes 54766-799-04 28.4 g in 1 tube, with applicator , 54766-799-64 30 tube, with applicator in 1 carton / 4 g in 1 tube, with applicator (54766-799-36), 54766-799-65 12 tube, with applicator in 1 carton / 4 g in 1 tube, with applicator (54766-799-36), 54766-799-71 30 tube, with applicator in 1 carton / 4 g in 1 tube, with applicator (54766-799-33), 54766-799-72 12 tube, with applicator in 1 carton / 4 g in 1 tube, with applicator (54766-799-33). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Analpram Hc?

    This combination medication is used to treat minor pain, itching, swelling, and discomfort caused by hemorrhoids and other problems of the anal area (e.g., anal fissures, itching). This medication contains pramoxine, an anesthetic that works by temporarily numbing the area. This product also contains hydrocortisone, a corticosteroid that reduces redness, itching, and swelling.

    What are Analpram Hc Active Ingredients?

    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 Analpram Hc UNII Codes?

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

    Which are Analpram Hc Inactive Ingredients 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 Analpram Hc?

    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: 1294025 - hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal Cream
    • RxCUI: 1294025 - hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
    • RxCUI: 1294025 - hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal Cream
    • RxCUI: 1362211 - Analpram 2.5 % / 1 % Rectal Cream
    • RxCUI: 1362211 - hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]

    Which are the Pharmacologic Classes for Analpram Hc?

    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 disclaimer below.

    Patient Education

    Hydrocortisone Rectal


    Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. 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 disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".