Norethisterone Powder
NDC Package 12866-1013-0
Package Information
Norethisterone powders is a medication used to prevent pregnancy. This formulation utilizes a powder delivery system. Marketed by Bayer Ag, this product is identified by NDC 12866-1013.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 12866 - Bayer Ag
- 12866-1013 -
- 12866-1013-0 - 21.23 kg in 1 CONTAINER
- 12866-1013 -
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 12866-1013-0 identifies a specific commercial package of 21.23 kg in 1 container of Norethisterone (UNFINISHED drug), a bulk ingredient labeled by Bayer Ag. This powder is formulated for use and contains norethindrone 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 Ag on May 13, 2017. The current certification is valid through December 31, 2026.
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 Bayer Ag product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 12866101300. 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 Package segment to maintain the 5-4-2 structure.