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  5. NDC Package Code: 45941-3054-1 Glycerol Phenylbutyrate

NDC Package 45941-3054-1 Glycerol Phenylbutyrate

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

Table of Contents

    1. Package Information
    2. 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:
45941-3054-1
Package Description:
200 kg in 1 DRUM
Product Code:
45941-3054
Non-Proprietary Name:
Glycerol Phenylbutyrate
Substance Name:
Glycerol 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. 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.
11-Digit NDC Billing Format:
45941305401
Product Type:
Bulk Ingredient
Labeler Name:
Patheon Austria Gmbh & Cokg
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):
  • GLYCEROL PHENYLBUTYRATE 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    01-10-2012
    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.

    Frequently Asked Questions

    What is NDC 45941-3054-1?

    The NDC Packaged Code 45941-3054-1 is assigned to an UNFINISHED drug package of 200 kg in 1 drum of Glycerol Phenylbutyrate, a bulk ingredient labeled by Patheon Austria Gmbh & Cokg. The product's dosage form is powder and is administered via form.

    Is NDC 45941-3054 included in the NDC Directory?

    Yes, Glycerol Phenylbutyrate is an UNFINISHED PRODUCT with code 45941-3054 that is active and included in the NDC Directory. The product was first marketed by Patheon Austria Gmbh & Cokg on January 10, 2012 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 45941-3054-1?

    The 11-digit format is 45941305401. 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 5-4-1 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
    5-4-145941-3054-15-4-245941-3054-01