Glycerol Phenylbutyrate Liquid
NDC Package 70710-2193-5

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

Package Information

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 Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-2193 and is authorized under FDA application ANDA220568.

Identification & Billing

NDC Package Code
70710-2193-5
Package Description
1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE
Product Code
70710-2193
11-Digit Billing Format
70710219305
RxNorm Crosswalk

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GLYCEROL PHENYLBUTYRATE 1.1 g/mL
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. 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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA220568
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-04-2026
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 70710-2193-5 identifies a specific commercial package of 1 bottle in 1 carton / 25 ml in 1 bottle of Glycerol Phenylbutyrate, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This liquid is formulated for oral 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 Zydus Pharmaceuticals Usa Inc. on May 04, 2026. 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. 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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710219305. 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 (5-4-1)
70710-2193-5
11-Digit CMS (5-4-2)
70710-2193-05

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