Endometrin Insert
NDC 55566-6500

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55566-6500?
  5. Endometrin Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Endometrin (progesterone) is a NDA-approved product labeled by Ferring Pharmaceuticals Inc.. This medication contains a female hormone called progesterone. It is supplied as a white insert for vaginal administration. This product entry covers the primary NDC 55566-6500 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
55566-6500
Proprietary Name:
Endometrin
Non-Proprietary Name: [1]
Progesterone
Substance Name: [2]
Progesterone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Ferring Pharmaceuticals Inc.
Labeler Code:
55566
Product Label ID:
2ba50fa9-b349-40cb-9a4b-1af8faa4ec09
FDA Application Number: [6]
NDA022057
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-21-2007
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Imprint(s):
FPI;100

Code Structure Chart

Product Details

What is NDC 55566-6500?

The NDC code 55566-6500 is assigned by the FDA to the product Endometrin. It is commonly known by its generic name, progesterone. This pharmaceutical product is labeled by Ferring Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a insert administered via vaginal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 55566-6500-3, 55566-6500-8. 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 contains a female hormone called progesterone. Progesterone is needed to prepare the lining of the uterus so it can receive a fertilized egg. Progesterone and other hormones help you become and stay pregnant. This medication is used to increase the level of progesterone in women taking fertility treatments because these treatments tend to decrease progesterone levels.

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.
  • PROGESTERONE 100 mg/1 - The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.

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:

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.

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Patient Education

Progesterone Vaginal


Vaginal progesterone (Crinone, Endometrin) is used as part of assisted reproductive technology (ART; fertility treatment) in women experiencing infertility (not getting pregnant despite having carefully timed, unprotected sex) who may need extra progesterone to help them become pregnant and to stay pregnant. Vaginal progesterone (Crinone) is also used to bring on menstruation (period) in women experiencing (absence of menstruation in women of childbearing age who have had normal periods and then stopped). Progesterone is in a class of medications called progestins (female hormones). It works as a part of ART by increase embryo implantation and decrease the risk of miscarriage. Once an embryo is implanted, progesterone acts to maintain the pregnancy. It works to bring on menstruation by replacing the natural progesterone that some women are missing. It works to bring on menstruation by replacing the natural progesterone that some women are missing.
[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".