Glycerol Phenylbutyrate Liquid
NDC Package 58159-034-01

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.

Glycerol Phenylbutyrate liquids is a medication used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). This formulation utilizes a liquid delivery system. Marketed by Nuray Chemicals Private Limited, this product is identified by NDC 58159-034.

Identification & Billing

NDC Package Code
58159-034-01
Package Description
35 kg in 1 BOTTLE
Product Code
58159-034
11-Digit Billing Format
58159003401

Clinical Specifications

Proprietary Name
Glycerol Phenylbutyrate
Non-Proprietary Name
Glycerol Phenylbutyrate
Substance Name
Glycerol Phenylbutyrate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
GLYCEROL PHENYLBUTYRATE 35 kg/35kg
Usage Information
This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). It helps remove a certain chemical (ammonia) from the body. Too much ammonia in the body can cause brain damage and sometimes death. This medication should not be used to treat sudden, severely high levels of ammonia in the body. Get medical help right away if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, trouble speaking, trouble walking, fainting.

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
10-01-2019
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 (58159-034). Click a package code to view its specific billing and regulatory data.

58159-034-02
20 kg in 1 BOTTLE
58159-034-03
15 kg in 1 BOTTLE
58159-034-04
10 kg in 1 BOTTLE
58159-034-05
5 kg in 1 BOTTLE

* 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 58159-034-01 identifies a specific commercial package of 35 kg in 1 bottle of Glycerol Phenylbutyrate (UNFINISHED drug), a bulk ingredient labeled by Nuray Chemicals Private Limited. This liquid is formulated for use and contains glycerol phenylbutyrate 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 October 01, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). It helps remove a certain chemical (ammonia) from the body. Too much ammonia in the body can cause brain damage and sometimes death. This medication should not be used to treat sudden, severely high levels of ammonia in the body. Get medical help right away if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, trouble speaking, trouble walking, fainting.

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: 58159003401. 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)
58159-034-01
11-Digit CMS (5-4-2)
58159-0034-01

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