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  5. NDC Package Code: 58159-095-03 Sodium Phenyl Butyrate

NDC Package 58159-095-03 Sodium Phenyl Butyrate

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
58159-095-03
Package Description:
15 kg in 1 DRUM
Product Code:
58159-095
Non-Proprietary Name:
Sodium Phenyl Butyrate
Substance 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:
58159009503
Product Type:
Bulk Ingredient
Labeler Name:
Nuray Chemicals Private Limited
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • SODIUM PHENYLBUTYRATE 35 kg/35kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    04-13-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58159-095-0135 kg in 1 DRUM
    58159-095-0220 kg in 1 DRUM
    58159-095-0410 kg in 1 DRUM
    58159-095-055 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58159-095-03?

    The NDC Packaged Code 58159-095-03 is assigned to an UNFINISHED drug package of 15 kg in 1 drum of Sodium Phenyl Butyrate, a bulk ingredient labeled by Nuray Chemicals Private Limited. The product's dosage form is powder and is administered via form.

    Is NDC 58159-095 included in the NDC Directory?

    Yes, Sodium Phenyl Butyrate is an UNFINISHED PRODUCT with code 58159-095 that is active and included in the NDC Directory. The product was first marketed by Nuray Chemicals Private Limited on April 13, 2023 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 11-digit format for NDC 58159-095-03?

    The 11-digit format is 58159009503. 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
    5-3-258159-095-035-4-258159-0095-03