Lysteda
NDC Package 55566-2100-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Lysteda is a medication used to treat heavy bleeding during your menstrual period. Marketed by Ferring Pharmaceuticals Inc., this product is identified by NDC 55566-2100 and is authorized under FDA application NDA022430.

Identification & Billing

NDC Package Code
55566-2100-2
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
Product Code
55566-2100
11-Digit Billing Format
55566210002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Lysteda
Dosage Form
-
Usage Information
This medication is used to treat heavy bleeding during your menstrual period. Tranexamic acid works by slowing the breakdown of blood clots, which helps to prevent prolonged bleeding. It belongs to a class of drugs known as antifibrinolytics. Tranexamic acid is not a hormone. It does not treat other menstrual or pre-menstrual symptoms. It does not stop your period. It is not a form of birth control and does not protect against sexually transmitted diseases.

Regulatory & Marketing

Labeler Name
Ferring Pharmaceuticals Inc.
FDA Application #
NDA022430
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-17-2010
End Marketing Date
12-31-2015
Listing Expiration
12-31-2015
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55566-2100). Click a package code to view its specific billing and regulatory data.

55566-2100-1
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE

* 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 55566-2100-2 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet in 1 bottle of Lysteda, labeled by Ferring Pharmaceuticals Inc.. 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 Ferring Pharmaceuticals Inc. on May 17, 2010. The current certification is valid through December 31, 2015.

What are the primary indications for this medication?

This medication is used to treat heavy bleeding during your menstrual period. Tranexamic acid works by slowing the breakdown of blood clots, which helps to prevent prolonged bleeding. It belongs to a class of drugs known as antifibrinolytics. Tranexamic acid is not a hormone. It does not treat other menstrual or pre-menstrual symptoms. It does not stop your period. It is not a form of birth control and does not protect against sexually transmitted diseases.

How is this Ferring Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55566210002. 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:

10-Digit Format (5-4-1)
55566-2100-2
11-Digit CMS (5-4-2)
55566-2100-02

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