NDC 50419-424 Kyleena

Levonorgestrel Intrauterine Device Intrauterine - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
50419-424
Proprietary Name:
Kyleena
Non-Proprietary Name: [1]
Levonorgestrel
Substance Name: [2]
Levonorgestrel
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Intrauterine Device - A device inserted and left in the uterus to prevent effective conception.
Administration Route(s): [4]
  • Intrauterine - Administration within the uterus.
  • Labeler Name: [5]
    Bayer Healthcare Pharmaceuticals Inc.
    Labeler Code:
    50419
    FDA Application Number: [6]
    NDA208224
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-19-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 50419-424-01

    Package Description: 1 INTRAUTERINE DEVICE in 1 CARTON

    NDC Code 50419-424-08

    Package Description: 1 INTRAUTERINE DEVICE in 1 CARTON

    NDC Code 50419-424-71

    Package Description: 1 INTRAUTERINE DEVICE in 1 CARTON

    Product Details

    What is NDC 50419-424?

    The NDC code 50419-424 is assigned by the FDA to the product Kyleena which is a human prescription drug product labeled by Bayer Healthcare Pharmaceuticals Inc.. The generic name of Kyleena is levonorgestrel. The product's dosage form is intrauterine device and is administered via intrauterine form. The product is distributed in 3 packages with assigned NDC codes 50419-424-01 1 intrauterine device in 1 carton , 50419-424-08 1 intrauterine device in 1 carton , 50419-424-71 1 intrauterine device in 1 carton . 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 Kyleena?

    This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is used by women who want to use a reversible birth control method that works for a long time (up to 5 years). It is also used to treat heavy menstrual bleeding in women who choose to use this birth control method. The device slowly releases a hormone (levonorgestrel) that is similar to a hormone that women normally make. This device helps prevent pregnancy by making cervical fluid thicker, interfering with sperm movement, and reducing sperm survival to prevent sperm from reaching an egg (fertilization). It also changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This device may also stop the release of an egg from your ovary (ovulation), but this is not the way it works in most women. Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

    What are Kyleena 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.
    • LEVONORGESTREL 19.5 mg/1 - A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

    Which are Kyleena UNII Codes?

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

    Which are Kyleena 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 Kyleena?

    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 Kyleena?

    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

    Levonorgestrel Intrauterine System


    Levonorgestrel intrauterine system (Liletta, Kyleena, Mirena, Skyla) is used to prevent pregnancy. The Mirena brand intrauterine system is also used to treat heavy menstrual bleeding in women who want to use an intrauterine system to prevent pregnancy. Levonorgestrel is in a class of medications called hormonal contraceptives. Levonorgestrel intrauterine system works by thinning the lining of the uterus (womb) to prevent pregnancy from developing, thickening the mucus at the cervix (entrance to the uterus) to prevent sperm from entering, and preventing sperm from moving and surviving in the uterus. Levonorgestrel may also prevent ovulation (release of an egg from the ovaries) in some women. Levonorgestrel intrauterine system is an effective method of birth control but it does not prevent the spread of AIDS and other sexually transmitted diseases.
    [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".