Sodium Phenylbutyrate
NDC Package 46672-851-25

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sodium Phenylbutyrate is a medication used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). Marketed by Mikart, Llc, this product is identified by NDC 46672-851 and is authorized under FDA application ANDA090910.

Identification & Billing

NDC Package Code
46672-851-25
Package Description
250 TABLET in 1 BOTTLE, PLASTIC
Product Code
46672-851
11-Digit Billing Format
46672085125

Clinical Specifications

Proprietary Name
Sodium Phenylbutyrate
Dosage Form
-
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
Mikart, Llc
FDA Application #
ANDA090910
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2011
End Marketing Date
11-19-2011
Listing Expiration
11-19-2011
Exclude Flag
D
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 46672-851-25 identifies a specific commercial package of 250 tablet in 1 bottle, plastic of Sodium Phenylbutyrate, labeled by Mikart, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mikart, Llc on November 18, 2011. The current certification is valid through November 19, 2011.

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 Mikart, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46672085125. 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)
46672-851-25
11-Digit CMS (5-4-2)
46672-0851-25

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