Femring
NDC 72495-201

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 72495-201?
  4. Femring 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

Femring (estradiol acetate) is a NDA-approved product labeled by Millicent Us, Inc.. This medication is a female hormone (estrogen). It is supplied as a ring for vaginal administration. This product entry covers the primary NDC 72495-201 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
72495-201
Proprietary Name:
Femring
Non-Proprietary Name: [1]
Estradiol Acetate
Substance Name: [2]
Estradiol Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Ring - A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects.
Administration Route(s): [4]
Vaginal - Administration into the vagina.

Labeler & Regulatory Data

Labeler Name: [5]
Millicent Us, Inc.
Labeler Code:
72495
Product Label ID:
7aaa97f9-a9d1-c815-e053-2991aa0afb9e
FDA Application Number: [6]
NDA021367
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-10-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 72495-201?

The NDC code 72495-201 is assigned by the FDA to the product Femring. It is commonly known by its generic name, estradiol acetate. This pharmaceutical product is labeled by Millicent Us, Inc. and is currently categorized as listed product. The medication is a ring administered via vaginal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 72495-201-05. 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?

This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). 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, other products applied directly inside the vagina (such as cream, vaginal tablet) should be considered before this product.

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: 848331 - estradiol acetate 0.05 MG per 24HR 3 Month Vaginal System
  • RxCUI: 848331 - 90 DAY estradiol 0.00208 MG/HR Vaginal System
  • RxCUI: 848331 - estradiol 0.05 MG per 24 HR Vaginal System, 90 Day
  • RxCUI: 848333 - Femring 0.05 MG per 24HR 3 Month Vaginal System
  • RxCUI: 848333 - 90 DAY estradiol 0.00208 MG/HR Vaginal System [Femring]

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

Estrogen Vaginal


Vaginal estrogen is used to treat vaginal dryness, itching, and burning; painful or difficult urination; and sudden need to urinate immediately in women who are experiencing or have experienced menopause (change of life; the end of monthly menstrual periods). Femring® brand vaginal ring is also used to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause. Premarin® brand vaginal cream is also used to treat kraurosis vulvae (a condition that may cause vaginal dryness and discomfort in women or girls of any age). Imvexxy® brand vaginal inserts are used for the treatment of dyspareunia (difficult or painful sexual intercourse) in menopausal women. Vaginal estrogen is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
[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 Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".