NDC Package 72542-600-18 Olpruva

Sodium Phenylbutyrate Kit Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
Olpruva
Non-Proprietary Name:
Sodium Phenylbutyrate
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.
11-Digit NDC Billing Format:
72542060018
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2626369 - sodium phenylbutyrate 2 GM Granules for Oral Suspension
  • RxCUI: 2626369 - sodium phenylbutyrate 2000 MG Granules for Oral Suspension
  • RxCUI: 2626375 - OLPRUVA 2 GM Granules for Oral Suspension
  • RxCUI: 2626375 - sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]
  • RxCUI: 2626375 - Olpruva 2 GM Granules for Oral Suspension
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Acer Therapeutics Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    NDA214860
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-22-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 72542-600-18?

    The NDC Packaged Code 72542-600-18 is assigned to a 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.. The product's dosage form is kit and is administered via oral form.

    Is NDC 72542-600 included in the NDC Directory?

    Yes, Olpruva with product code 72542-600 is active and included in the NDC Directory. The product was first marketed by Acer Therapeutics Inc. on December 22, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 72542-600-18?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 72542-600-18?

    The 11-digit format is 72542060018. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-272542-600-185-4-272542-0600-18