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NDC 72542-600 Olpruva

Sodium Phenylbutyrate Kit Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 72542-600?
  4. Olpruva Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
72542-600
Proprietary Name:
Olpruva
Non-Proprietary Name: [1]
Sodium Phenylbutyrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Acer Therapeutics Inc.
    Labeler Code:
    72542
    Product Label ID:
    89abc31c-43e8-4809-9eb7-172cb31a86f1
    FDA Application Number: [6]
    NDA214860
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    12-22-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC 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 Details

    What is NDC 72542-600?

    The NDC code 72542-600 is assigned by the FDA to the product Olpruva which is a human prescription drug product labeled by Acer Therapeutics Inc.. The generic name of Olpruva is sodium phenylbutyrate. The product's dosage form is kit and is administered via oral form. The product is distributed in a single package with assigned NDC code 72542-600-18 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). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Olpruva?

    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.

    Which are Olpruva UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Olpruva Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Olpruva?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".