Kyleena Intrauterine Device
NDC Package 50419-424-71

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Kyleena (levonorgestrel) intrauterine devices is a medication a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. This formulation utilizes a intrauterine device delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-424 and is authorized under FDA application NDA208224.

Identification & Billing

NDC Package Code
50419-424-71
Package Description
1 INTRAUTERINE DEVICE in 1 CARTON
Product Code
50419-424
11-Digit Billing Format
50419042471
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kyleena
Non-Proprietary Name
Levonorgestrel
Substance Name
Levonorgestrel
Dosage Form
Intrauterine Device - A device inserted and left in the uterus to prevent effective conception.
Administration Route
Intrauterine - Administration within the uterus.
Active Ingredient(s)
LEVONORGESTREL 19.5 mg/1
Pharmacologic Class
Usage Information
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).

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208224
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-19-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50419-424). Click a package code to view its specific billing and regulatory data.

50419-424-01
1 INTRAUTERINE DEVICE in 1 CARTON
50419-424-08
1 INTRAUTERINE DEVICE in 1 CARTON

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50419-424-71 identifies a specific commercial package of 1 intrauterine device in 1 carton of Kyleena, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This intrauterine device is formulated for intrauterine use and contains levonorgestrel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bayer Healthcare Pharmaceuticals Inc. on September 19, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Bayer Healthcare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419042471. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50419-424-71
11-Digit CMS (5-4-2)
50419-0424-71

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.