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  5. NDC Package Code: 68462-853-20 Sodium Phenylbutyrate

NDC Package 68462-853-20 Sodium Phenylbutyrate

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
68462-853-20
Package Description:
250 TABLET in 1 BOTTLE
Product Code:
68462-853
Proprietary Name:
Sodium Phenylbutyrate
Non-Proprietary Name:
Sodium Phenylbutyrate
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:
68462085320
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
250 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 199369 - sodium phenylbutyrate 500 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Glenmark Pharmaceuticals Inc., Usa
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM PHENYLBUTYRATE 500 mg/1
    • Pharmacologic Class(es):
  • Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
  • Nitrogen Binding Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216462
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2022
    Listing Expiration Date:
    12-31-2025
    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 68462-853-20?

    The NDC Packaged Code 68462-853-20 is assigned to a package of 250 tablet in 1 bottle of Sodium Phenylbutyrate, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 250 billable units per package.

    Is NDC 68462-853 included in the NDC Directory?

    Yes, Sodium Phenylbutyrate with product code 68462-853 is active and included in the NDC Directory. The product was first marketed by Glenmark Pharmaceuticals Inc., Usa on November 01, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68462-853-20?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 250.

    What is the 11-digit format for NDC 68462-853-20?

    The 11-digit format is 68462085320. 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
    5-3-268462-853-205-4-268462-0853-20