Tranexamic Acid Powder
NDC Package 59680-012-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tranexamic Acid powders is a medication used to treat heavy bleeding during your menstrual period. This formulation utilizes a powder delivery system. Marketed by Ami Lifesciences Private Limited, this product is identified by NDC 59680-012.

Identification & Billing

NDC Package Code
59680-012-00
Package Description
25 kg in 1 DRUM
Product Code
59680-012
11-Digit Billing Format
59680001200

Clinical Specifications

Proprietary Name
Tranexamic Acid
Non-Proprietary Name
Tranexamic Acid
Substance Name
Tranexamic Acid Dimer
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TRANEXAMIC ACID DIMER 1 kg/kg
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
Ami Lifesciences Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-14-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 59680-012-00 identifies a specific commercial package of 25 kg in 1 drum of Tranexamic Acid (UNFINISHED drug), a bulk ingredient labeled by Ami Lifesciences Private Limited. This powder is formulated for use and contains tranexamic acid dimer 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 Ami Lifesciences Private Limited on July 14, 2023. The current certification is valid through December 31, 2026.

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 Ami Lifesciences Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59680001200. 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)
59680-012-00
11-Digit CMS (5-4-2)
59680-0012-00

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