Affodel Tablet
NDC Package 79929-015-07

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

Package Information

Affodel (norethindrone) tablets is a medication used to prevent pregnancy. This formulation utilizes a tablet delivery system. Marketed by Naari Pte. Limited, this product is identified by NDC 79929-015 and is authorized under FDA application ANDA206807.

Identification & Billing

NDC Package Code
79929-015-07
Package Description
84 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK
Product Code
79929-015
11-Digit Billing Format
79929001507
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Affodel
Non-Proprietary Name
Norethindrone
Substance Name
Norethindrone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NORETHINDRONE .35 mg/1
Pharmacologic Class
Usage Information
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).

Regulatory & Marketing

Labeler Name
Naari Pte. Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206807
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 79929-015-07 identifies a specific commercial package of 84 blister pack in 1 carton / 28 tablet in 1 blister pack of Affodel, a human prescription drug labeled by Naari Pte. Limited. This tablet is formulated for oral 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 Naari Pte. Limited on May 31, 2024. 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 Naari Pte. Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79929001507. 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)
79929-015-07
11-Digit CMS (5-4-2)
79929-0015-07

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