Inc-15-ruxo Phosphate Powder
NDC Package 0792-3940-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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.

Inc-15-ruxo Phosphate powders is a medication used to treat certain bone marrow disorders (myelofibrosis, polycythemia vera). This formulation utilizes a powder delivery system. Marketed by Siegfried Usa, Llc, this product is identified by NDC 0792-3940.

Identification & Billing

NDC Package Code
0792-3940-00
Package Description
50 kg in 1 DRUM
Product Code
11-Digit Billing Format
00792394000

Clinical Specifications

Proprietary Name
Inc-15-ruxo Phosphate
Non-Proprietary Name
Inc-15-ruxo Phosphate
Substance Name
Ruxolitinib Phosphate
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)
Usage Information
This medication is used to treat certain bone marrow disorders (myelofibrosis, polycythemia vera). It works by blocking your body from producing substances called growth factors. Growth factors cause cells to grow and divide, and cause the blood cell and spleen problems found in these disorders. Ruxolitinib belongs to a class of drugs known as kinase inhibitors. Though not a cure for these disorders, ruxolitinib may help with some of the symptoms, including abdominal discomfort, pain under left ribs, early feelings of fullness from meals, night sweats, itching, and bone/muscle pain. Ruxolitinib is also used to treat a certain problem that may occur after certain stem cell or bone marrow transplants (graft versus host disease). It works by weakening your body's defense system (immune system).

Regulatory & Marketing

Labeler Name
Siegfried Usa, Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-26-2024
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 0792-3940-00 identifies a specific commercial package of 50 kg in 1 drum of Inc-15-ruxo Phosphate (UNFINISHED drug), a bulk ingredient labeled by Siegfried Usa, Llc. This powder is formulated for use and contains ruxolitinib phosphate 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 Siegfried Usa, Llc on July 26, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain bone marrow disorders (myelofibrosis, polycythemia vera). It works by blocking your body from producing substances called growth factors. Growth factors cause cells to grow and divide, and cause the blood cell and spleen problems found in these disorders. Ruxolitinib belongs to a class of drugs known as kinase inhibitors. Though not a cure for these disorders, ruxolitinib may help with some of the symptoms, including abdominal discomfort, pain under left ribs, early feelings of fullness from meals, night sweats, itching, and bone/muscle pain. Ruxolitinib is also used to treat a certain problem that may occur after certain stem cell or bone marrow transplants (graft versus host disease). It works by weakening your body's defense system (immune system).

How is this Siegfried Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00792394000. 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 (4-4-2)
0792-3940-00
11-Digit CMS (5-4-2)
00792-3940-00

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