Mononessa
NDC Package 76413-166-28

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Mononessa is this combination hormone medication is used to prevent pregnancy. Marketed by Central Texas Community Health Centers, this product is identified by NDC 76413-166 and is authorized under FDA application NDA019653.

Identification & Billing

NDC Package Code
76413-166-28
Package Description
1 KIT in 1 CARTON
Product Code
76413-166
11-Digit Billing Format
76413016628
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mononessa
Dosage Form
-
Usage Information
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and 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. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Central Texas Community Health Centers
FDA Application #
NDA019653
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2003
Listing Expiration
12-31-2020
Exclude Flag
I
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 76413-166-28 identifies a specific commercial package of 1 kit in 1 carton of Mononessa, labeled by Central Texas Community Health Centers. 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 Central Texas Community Health Centers on January 01, 2003. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and 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. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Central Texas Community Health Centers product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76413016628. 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)
76413-166-28
11-Digit CMS (5-4-2)
76413-0166-28

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