Tranexamic Acid
NDC Package 17478-017-10

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 discontinued by the firm.

Tranexamic Acid is a medication used to treat heavy bleeding during your menstrual period. Marketed by Akorn, this product is identified by NDC 17478-017 and is authorized under FDA application ANDA206634.

Identification & Billing

NDC Package Code
17478-017-10
Package Description
5 AMPULE in 1 CARTON / 10 mL in 1 AMPULE
Product Code
17478-017
11-Digit Billing Format
17478001710

Clinical Specifications

Proprietary Name
Tranexamic Acid
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
Akorn
FDA Application #
ANDA206634
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-09-2016
End Marketing Date
05-18-2022
Listing Expiration
05-18-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17478-017-10 identifies a specific commercial package of 5 ampule in 1 carton / 10 ml in 1 ampule of Tranexamic Acid, labeled by Akorn. 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 Akorn on June 09, 2016. The current certification is valid through May 18, 2022.

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 Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478001710. 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)
17478-017-10
11-Digit CMS (5-4-2)
17478-0017-10

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