NDC 0037-4801 Elestrin

Estradiol Gel, Metered Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0037-4801
Proprietary Name:
Elestrin
Non-Proprietary Name: [1]
Estradiol
Substance Name: [2]
Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.
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]
    Meda Pharmaceuticals Inc.
    Labeler Code:
    0037
    FDA Application Number: [6]
    NDA021813
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-02-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0037-4801-70

    Package Description: 2 BOTTLE, PUMP in 1 CARTON / 35 g in 1 BOTTLE, PUMP (0037-4801-35)

    Price per Unit: $3.47917 per GM

    Product Details

    What is NDC 0037-4801?

    The NDC code 0037-4801 is assigned by the FDA to the product Elestrin which is a human prescription drug product labeled by Meda Pharmaceuticals Inc.. The generic name of Elestrin is estradiol. The product's dosage form is gel, metered and is administered via topical form. The product is distributed in a single package with assigned NDC code 0037-4801-70 2 bottle, pump in 1 carton / 35 g in 1 bottle, pump (0037-4801-35). 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 Elestrin?

    This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Certain brands may also help to reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

    What are Elestrin 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.
    • ESTRADIOL .52 mg/.87g - The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.

    Which are Elestrin UNII Codes?

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

    Which are Elestrin 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:

    Which are the Pharmacologic Classes for Elestrin?

    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

    Estradiol Topical


    Estradiol topical gel and emulsion (lotion type mixture) are used to treat and prevent hot flushes (hot flashes; sudden strong feelings of heat and sweating) in women who are experiencing menopause (change of life; the end of monthly menstrual periods). Estradiol topical gel is also used to treat vaginal dryness, itching, and burning in women who are experiencing menopause. However, women whose only bothersome symptoms are vaginal burning, itching, and dryness may benefit more from a medication that is applied topically to the vagina. Estradiol is in a class of medications called estrogen hormones. It works by replacing estrogen that is normally produced by the body.
    [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.

    [6] 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.

    [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".