Nitisinone Powder
NDC Package 58159-037-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Nitisinone powders is nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). This formulation utilizes a powder delivery system. Marketed by Nuray Chemicals Private Limited, this product is identified by NDC 58159-037.

Identification & Billing

NDC Package Code
58159-037-03
Package Description
15 kg in 1 DRUM
Product Code
58159-037
11-Digit Billing Format
58159003703

Clinical Specifications

Proprietary Name
Nitisinone
Non-Proprietary Name
Nitisinone
Substance Name
Nitisinone
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)
NITISINONE 35 kg/35kg
Usage Information
Nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). HT-1 is usually discovered in infants and needs lifelong treatment. This condition is caused by a shortage of a certain natural substance that is needed to break down a nutrient (tyrosine) found in food. This effect causes a build-up of too much tyrosine and related substances in the liver. Nitisinone works by helping to prevent the formation and build-up of several toxic substances that cause damage to the liver, kidneys, and nervous system. This drug must be used along with a diet low in protein, tyrosine, and phenylalanine.

Regulatory & Marketing

Labeler Name
Nuray Chemicals 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
12-09-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58159-037). Click a package code to view its specific billing and regulatory data.

58159-037-01
35 kg in 1 DRUM
58159-037-02
20 kg in 1 DRUM
58159-037-04
10 kg in 1 DRUM
58159-037-05
5 kg in 1 DRUM

* 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 58159-037-03 identifies a specific commercial package of 15 kg in 1 drum of Nitisinone (UNFINISHED drug), a bulk ingredient labeled by Nuray Chemicals Private Limited. This powder is formulated for use and contains nitisinone 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 Nuray Chemicals Private Limited on December 09, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Nitisinone is used to treat a certain inherited disorder (hereditary tyrosinemia type 1, also known as HT-1). HT-1 is usually discovered in infants and needs lifelong treatment. This condition is caused by a shortage of a certain natural substance that is needed to break down a nutrient (tyrosine) found in food. This effect causes a build-up of too much tyrosine and related substances in the liver. Nitisinone works by helping to prevent the formation and build-up of several toxic substances that cause damage to the liver, kidneys, and nervous system. This drug must be used along with a diet low in protein, tyrosine, and phenylalanine.

How is this Nuray Chemicals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58159003703. 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)
58159-037-03
11-Digit CMS (5-4-2)
58159-0037-03

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