Tafamidis Powder
NDC Package 69988-0039-1

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.

Tafamidis powders is a medication used to treat a certain type of heart failure (transthyretin-mediated amyloidosis). This formulation utilizes a powder delivery system. Marketed by Catalent Micron Technologies, Inc., this product is identified by NDC 69988-0039.

Identification & Billing

NDC Package Code
69988-0039-1
Package Description
1 BAG in 1 DRUM / 25 POWDER in 1 BAG
Product Code
69988-0039
11-Digit Billing Format
69988003901

Clinical Specifications

Proprietary Name
Tafamidis
Non-Proprietary Name
Tafamidis
Substance Name
Tafamidis
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)
TAFAMIDIS 1 kg/1
Usage Information
This medication is used to treat a certain type of heart failure (transthyretin-mediated amyloidosis). It is used to help prevent the heart failure from getting worse and needing treatment in a hospital. Tafamidis works by slowing the buildup of a certain protein (amyloid fibrils) that causes heart problems.

Regulatory & Marketing

Labeler Name
Catalent Micron Technologies, Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-02-2001
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 69988-0039-1 identifies a specific commercial package of 1 bag in 1 drum / 25 powder in 1 bag of Tafamidis (UNFINISHED drug), drug for further processing labeled by Catalent Micron Technologies, Inc.. This powder is formulated for use and contains tafamidis 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 Catalent Micron Technologies, Inc. on July 02, 2001. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of heart failure (transthyretin-mediated amyloidosis). It is used to help prevent the heart failure from getting worse and needing treatment in a hospital. Tafamidis works by slowing the buildup of a certain protein (amyloid fibrils) that causes heart problems.

How is this Catalent Micron Technologies, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69988003901. 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)
69988-0039-1
11-Digit CMS (5-4-2)
69988-0039-01

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