Olpruva Kit
NDC Package 72542-600-18

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

Package Information

Olpruva (sodium phenylbutyrate) kits is a medication used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). This formulation utilizes a kit delivery system. Marketed by Acer Therapeutics Inc., this product is identified by NDC 72542-600 and is authorized under FDA application NDA214860.

Identification & Billing

NDC Package Code
72542-600-18
Package Description
90 BOX in 1 CARTON / 1 KIT in 1 BOX (72542-600-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)
Product Code
72542-600
11-Digit Billing Format
72542060018
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Olpruva
Non-Proprietary Name
Sodium Phenylbutyrate
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
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
Acer Therapeutics Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214860
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-22-2022
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 72542-600-18 identifies a specific commercial package of 90 box in 1 carton / 1 kit in 1 box (72542-600-02) * 1 for suspension in 1 packet (72542-003-01) * 1 for suspension in 1 packet (72542-000-01) of Olpruva, a human prescription drug labeled by Acer Therapeutics Inc.. This kit is formulated for oral use and contains 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 Acer Therapeutics Inc. on December 22, 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 Acer Therapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72542060018. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
72542-600-18
11-Digit CMS (5-4-2)
72542-0600-18

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