Lyza
NDC Package 50102-100-48
Package Information
Lyza is a medication used to prevent pregnancy. Marketed by Afaxys Pharma Llc, this product is identified by NDC 50102-100 and is authorized under FDA application ANDA200980.
Identification & Billing
- RxCUI: 1430383 - {28 (norethindrone 0.35 MG Oral Tablet) } Pack [Lyza]
- RxCUI: 1430383 - Lyza 28 Day Pack
- RxCUI: 198042 - norethindrone 0.35 MG Oral Tablet
- RxCUI: 748961 - {28 (norethindrone 0.35 MG Oral Tablet) } Pack
- RxCUI: 748961 - Noreth 0.35 MG (28) Oral Tablet 28 Day Pack
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50102 - Afaxys Pharma Llc
- 50102-100 - Lyza
- 50102-100-48 - 48 PACKAGE in 1 CASE / 1 BLISTER PACK in 1 PACKAGE (50102-100-01) / 28 TABLET in 1 BLISTER PACK (50102-100-00)
- 50102-100 - Lyza
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 (50102-100). Click a package code to view its specific billing and regulatory data.
* 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 50102-100-48 identifies a specific commercial package of 48 package in 1 case / 1 blister pack in 1 package (50102-100-01) / 28 tablet in 1 blister pack (50102-100-00) of Lyza, labeled by Afaxys Pharma Llc. 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 Afaxys Pharma Llc on June 24, 2013. The current certification is valid through December 31, 2022.
What are the primary indications for this medication?
This medication is used to prevent pregnancy. It is often referred to as the "mini-pill" because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changing 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 medication also stops the release of an egg (ovulation) in about half of a woman's menstrual cycles. While the "mini-pill" is more effective than certain other methods of birth control (such as condoms, cervical cap, diaphragm), it is less effective than combination hormone (estrogen and progestin) birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. To reduce the risk of pregnancy, it is very important to take this medication exactly as prescribed. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
How is this Afaxys Pharma Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50102010048. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 48 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.