Deutivacaftor Spray Dried Dispersion Powder
NDC Package 50909-1908-1

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.

Deutivacaftor Spray Dried Dispersion powders is a drug for further processing. This formulation utilizes a powder delivery system. Marketed by Hovione Farmaciencia Sa, this product is identified by NDC 50909-1908.

Identification & Billing

NDC Package Code
50909-1908-1
Package Description
25 kg in 1 DRUM
Product Code
50909-1908
11-Digit Billing Format
50909190801

Clinical Specifications

Proprietary Name
Deutivacaftor Spray Dried Dispersion
Non-Proprietary Name
Deutivacaftor Spray Dried Dispersion
Substance Name
Deutivacaftor
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)
DEUTIVACAFTOR .8 kg/kg

Regulatory & Marketing

Labeler Name
Hovione Farmaciencia Sa
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
12-20-2024
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 50909-1908-1 identifies a specific commercial package of 25 kg in 1 drum of Deutivacaftor Spray Dried Dispersion (UNFINISHED drug), drug for further processing labeled by Hovione Farmaciencia Sa. This powder is formulated for use and contains deutivacaftor 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 Hovione Farmaciencia Sa on December 20, 2024. The current certification is valid through December 31, 2026.

How is this Hovione Farmaciencia Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50909190801. 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)
50909-1908-1
11-Digit CMS (5-4-2)
50909-1908-01

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