Tenofovir Alafenamide Hemifumarate Powder
NDC Package 69766-059-01

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.

Tenofovir Alafenamide Hemifumarate powders is tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. This formulation utilizes a powder delivery system. Marketed by Msn Life Sciences Private Limited, this product is identified by NDC 69766-059.

Identification & Billing

NDC Package Code
69766-059-01
Package Description
50 kg in 1 DRUM
Product Code
69766-059
11-Digit Billing Format
69766005901

Clinical Specifications

Proprietary Name
Tenofovir Alafenamide Hemifumarate
Non-Proprietary Name
Tenofovir Alafenamide Hemifumarate
Substance Name
Tenofovir Alafenamide
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)
TENOFOVIR ALAFENAMIDE 1 kg/kg
Usage Information
Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if tenofovir alafenamide can cure hepatitis B or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

Regulatory & Marketing

Labeler Name
Msn Life Sciences 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
12-12-2018
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 69766-059-01 identifies a specific commercial package of 50 kg in 1 drum of Tenofovir Alafenamide Hemifumarate (UNFINISHED drug), a bulk ingredient labeled by Msn Life Sciences Private Limited. This powder is formulated for use and contains tenofovir alafenamide 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 Msn Life Sciences Private Limited on December 12, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if tenofovir alafenamide can cure hepatitis B or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

How is this Msn Life Sciences Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69766005901. 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)
69766-059-01
11-Digit CMS (5-4-2)
69766-0059-01

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