Tranexamic Acid
NDC Package 39822-1001-7

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 Xgen Pharmaceuticals Djb, Inc., this product is identified by NDC 39822-1001 and is authorized under FDA application ANDA201580.

Identification & Billing

NDC Package Code
39822-1001-7
Package Description
10 VIAL in 1 CARTON / 10 mL in 1 VIAL (39822-1001-6)
Product Code
39822-1001
11-Digit Billing Format
39822100107
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

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
Xgen Pharmaceuticals Djb, Inc.
FDA Application #
ANDA201580
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-18-2012
End Marketing Date
12-15-2020
Listing Expiration
12-15-2020
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 39822-1001-7 identifies a specific commercial package of 10 vial in 1 carton / 10 ml in 1 vial (39822-1001-6) of Tranexamic Acid, labeled by Xgen Pharmaceuticals Djb, 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 Xgen Pharmaceuticals Djb, Inc. on May 18, 2012. The current certification is valid through December 15, 2020.

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 Xgen Pharmaceuticals Djb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39822100107. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
39822-1001-7
11-Digit CMS (5-4-2)
39822-1001-07

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