NDC 50419-424 Kyleena
Levonorgestrel Intrauterine Device Intrauterine - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 50419 - Bayer Healthcare Pharmaceuticals Inc.
- 50419-424 - Kyleena
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?
What are the uses for Kyleena?
What are Kyleena Active Ingredients?
- 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:
- LEVONORGESTREL (UNII: 5W7SIA7YZW)
- LEVONORGESTREL (UNII: 5W7SIA7YZW) (Active Moiety)
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:
- DIMETHICONE (UNII: 92RU3N3Y1O)
- BARIUM SULFATE (UNII: 25BB7EKE2E)
What is the NDC to RxNorm Crosswalk for Kyleena?
- RxCUI: 1811886 - levonorgestrel 19.5 MG Intrauterine System
- RxCUI: 1811886 - levonorgestrel 0.000729 MG/HR Intrauterine System
- RxCUI: 1811886 - levonorgestrel 17.5 MCG per 24 HR Intrauterine System
- RxCUI: 1856546 - Kyleena 19.5 MG Intrauterine System
- RxCUI: 1856546 - levonorgestrel 0.000729 MG/HR Intrauterine System [Kyleena]
Which are the Pharmacologic Classes for Kyleena?
- Inhibit Ovum Fertilization - [PE] (Physiologic Effect)
- Progesterone Congeners - [CS]
- Progestin - [EPC] (Established Pharmacologic Class)
- Progestin-containing Intrauterine Device - [EPC] (Established Pharmacologic Class)
* 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.
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* Please review the disclaimer below.
[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".