Sodium Phenylbutyrate Tablet
NDC Package 68462-853-20

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

Package Information

Sodium Phenylbutyrate tablets is a medication used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). This formulation utilizes a tablet delivery system. Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-853 and is authorized under FDA application ANDA216462.

Identification & Billing

NDC Package Code
68462-853-20
Package Description
250 TABLET in 1 BOTTLE
Product Code
68462-853
11-Digit Billing Format
68462085320
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
250 EA
RxNorm Crosswalk
RxCUI: 199369 - sodium phenylbutyrate 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sodium Phenylbutyrate
Non-Proprietary Name
Sodium Phenylbutyrate
Substance Name
Sodium Phenylbutyrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM PHENYLBUTYRATE 500 mg/1
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
Glenmark Pharmaceuticals Inc., Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA216462
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2022
Listing Expiration
12-31-2027
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 68462-853-20 identifies a specific commercial package of 250 tablet in 1 bottle of Sodium Phenylbutyrate, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. This product is billed for "EA" each discreet unit and contains an estimated amount of 250 billable units per package. This tablet 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 Glenmark Pharmaceuticals Inc., Usa on November 01, 2022. The current certification is valid through December 31, 2027.

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 Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462085320. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 250 total billable units per package. 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)
68462-853-20
11-Digit CMS (5-4-2)
68462-0853-20

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