Skyla Intrauterine Device
NDC 50419-422
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Skyla (levonorgestrel) is a NDA-approved product labeled by Bayer Healthcare Pharmaceuticals Inc.. This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is supplied as a intrauterine device for intrauterine administration. This product entry covers the primary NDC 50419-422 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
50419-422
Proprietary Name:
Skyla
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
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
50419
Product Label ID:
FDA Application Number: [6]
NDA203159
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-11-2013
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 50419-422?
The NDC code 50419-422 is assigned by the FDA to the product Skyla. It is commonly known by its generic name, levonorgestrel. This pharmaceutical product is labeled by Bayer Healthcare Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a intrauterine device administered via intrauterine route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 50419-422-01, 50419-422-08, 50419-422-71. 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 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 3 years). 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 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.
- LEVONORGESTREL 13.5 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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- LEVONORGESTREL (UNII: 5W7SIA7YZW)
- LEVONORGESTREL (UNII: 5W7SIA7YZW) (Active Moiety)
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:
- DIMETHICONE (UNII: 92RU3N3Y1O)
- BARIUM SULFATE (UNII: 25BB7EKE2E)
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: 1366334 - levonorgestrel 13.5 MG Intrauterine System
- RxCUI: 1366334 - levonorgestrel 0.000583 MG/HR Intrauterine System
- RxCUI: 1366334 - levonorgestrel 14 MCG per 24 HR Intrauterine System
- RxCUI: 1366339 - Skyla 13.5 MG Intrauterine System
- RxCUI: 1366339 - levonorgestrel 0.000583 MG/HR Intrauterine System [Skyla]
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
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.
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* 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".
