Mirena
NDC Package 50419-421-01
Package Information
Mirena is a medication a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-421 and is authorized under FDA application NDA021225.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50419 - Bayer Healthcare Pharmaceuticals Inc.
- 50419-421 - Mirena
- 50419-421-01 - 1 INTRAUTERINE DEVICE in 1 CARTON
- 50419-421 - Mirena
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50419-421-01 identifies a specific commercial package of 1 intrauterine device in 1 carton of Mirena, labeled by Bayer Healthcare Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bayer Healthcare Pharmaceuticals Inc. on October 01, 2009. The current certification is valid through November 10, 2017.
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: 50419042101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.