Pheburane Pellet
NDC Package 71770-210-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pheburane (sodium phenylbutyrate) pellets is a medication used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). This formulation utilizes a pellet delivery system. Marketed by Medunik Usa, this product is identified by NDC 71770-210 and is authorized under FDA application NDA216513.

Identification & Billing

NDC Package Code
71770-210-10
Package Description
174 g in 1 BOTTLE
Product Code
71770-210
11-Digit Billing Format
71770021010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pheburane
Non-Proprietary Name
Sodium Phenylbutyrate
Substance Name
Sodium Phenylbutyrate
Dosage Form
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM PHENYLBUTYRATE 483 mg/g
Pharmacologic Class
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. Seek immediate medical attention if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, trouble speaking, trouble walking, fainting.

Regulatory & Marketing

Labeler Name
Medunik Usa
Product Type
Human Prescription Drug
FDA Application #
NDA216513
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-14-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 71770-210-10 identifies a specific commercial package of 174 g in 1 bottle of Pheburane, a human prescription drug labeled by Medunik Usa. This pellet is formulated for oral use and contains sodium 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 Medunik Usa on September 14, 2022. 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. Seek immediate medical attention if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, trouble speaking, trouble walking, fainting.

How is this Medunik Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71770021010. 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)
71770-210-10
11-Digit CMS (5-4-2)
71770-0210-10

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