NDC 0023-6150 Crinone

Progesterone Gel Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0023-6150
Proprietary Name:
Crinone
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
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
  • Vaginal - Administration into the vagina.
  • Labeler Name: [5]
    Allergan, Inc.
    Labeler Code:
    0023
    FDA Application Number: [6]
    NDA020701
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-13-1997
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0023-6150-04

    Package Description: 6 APPLICATOR in 1 CARTON / 1.125 g in 1 APPLICATOR

    Product Details

    What is NDC 0023-6150?

    The NDC code 0023-6150 is assigned by the FDA to the product Crinone which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Crinone is progesterone. The product's dosage form is gel and is administered via vaginal form. The product is distributed in a single package with assigned NDC code 0023-6150-04 6 applicator in 1 carton / 1.125 g in 1 applicator. 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 Crinone?

    This medication is used to treat infertility in women who do not make enough of a certain natural hormone called progesterone. Progesterone works by preparing the lining of the womb to receive a fertilized egg. This hormone is needed to maintain pregnancy. This medication is also used to restore menstrual cycles in women whose cycles have stopped.

    What are Crinone 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.
    • PROGESTERONE 45 mg/1.125g - 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 Crinone UNII Codes?

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

    Which are Crinone 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 Crinone?

    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 Crinone?

    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

    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 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".