1. Home
  2. Labeler Index
  3. Mayne Pharma Llc
  4. NDC Product Code: 50261-110 Imvexxy

NDC 50261-110 Imvexxy

Estradiol Insert Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50261-110?
  5. Imvexxy Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
50261-110
Proprietary Name:
Imvexxy
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:
Insert - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects.
Administration Route(s): [4]
  • Vaginal - Administration into the vagina.
    • Labeler Name: [5]
    Mayne Pharma Llc
    Labeler Code:
    50261
    Product Label ID:
    104be9f2-a8f6-430e-9e01-2ee7cc1861f1
    FDA Application Number: [6]
    NDA208564
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-03-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - LIGHT PINK)
    Shape:
    TEAR (C48351)
    Size(s):
    18 MM
    Imprint(s):
    04
    10

    Product Packages

    NDC Code 50261-110-02

    Package Description: 1 BLISTER PACK in 1 CARTON / 2 INSERT in 1 BLISTER PACK

    NDC Code 50261-110-08

    Package Description: 1 BLISTER PACK in 1 CARTON / 8 INSERT in 1 BLISTER PACK

    Price per Unit: $25.86050 per EA

    NDC Code 50261-110-18

    Package Description: 1 BLISTER PACK in 1 CARTON / 18 INSERT in 1 BLISTER PACK

    Price per Unit: $25.84106 per EA

    Product Details

    What is NDC 50261-110?

    The NDC code 50261-110 is assigned by the FDA to the product Imvexxy which is a human prescription drug product labeled by Mayne Pharma Llc. The generic name of Imvexxy is estradiol. The product's dosage form is insert and is administered via vaginal form. The product is distributed in 3 packages with assigned NDC codes 50261-110-02 1 blister pack in 1 carton / 2 insert in 1 blister pack, 50261-110-08 1 blister pack in 1 carton / 8 insert in 1 blister pack, 50261-110-18 1 blister pack in 1 carton / 18 insert in 1 blister pack. 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 Imvexxy?

    This medication is a female hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

    What are Imvexxy 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 10 ug/1 - 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 Imvexxy UNII Codes?

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

    Which are Imvexxy 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 Imvexxy?

    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:

    Which are the Pharmacologic Classes for Imvexxy?

    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.

    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".