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  5. NDC Package Code: 51754-0105-8 Acetylcysteine

NDC Package 51754-0105-8 Acetylcysteine

Acetylcysteine Solution Solution Oral; Respiratory (inhalation) - 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:
51754-0105-8
Package Description:
3 VIAL in 1 CARTON / 30 mL in 1 VIAL
Product Code:
51754-0105
Proprietary Name:
Acetylcysteine
Non-Proprietary Name:
Acetylcysteine Solution
Substance Name:
Acetylcysteine
Usage Information:
When inhaled by mouth, acetylcysteine is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia). This effect helps you to clear the mucus from your lungs so that you can breathe easier. When taken by mouth, acetylcysteine is used to prevent liver damage from acetaminophen overdose.
11-Digit NDC Billing Format:
51754010508
NDC to RxNorm Crosswalk:
  • RxCUI: 307719 - acetylcysteine 20 % Inhalation Solution
  • RxCUI: 307719 - acetylcysteine 200 MG/ML Inhalation Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Exela Pharma Sciences, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • ACETYLCYSTEINE 200 mg/mL
    • Pharmacologic Class(es):
  • Antidote - [EPC] (Established Pharmacologic Class)
  • Antidote for Acetaminophen Overdose - [EPC] (Established Pharmacologic Class)
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Increased Glutathione Concentration - [PE] (Physiologic Effect)
  • Mucolytic - [EPC] (Established Pharmacologic Class)
  • Reduction Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA205643
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-13-2023
    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 51754-0105-8?

    The NDC Packaged Code 51754-0105-8 is assigned to a package of 3 vial in 1 carton / 30 ml in 1 vial of Acetylcysteine, a human prescription drug labeled by Exela Pharma Sciences, Llc. The product's dosage form is solution and is administered via oral; respiratory (inhalation) form.

    Is NDC 51754-0105 included in the NDC Directory?

    Yes, Acetylcysteine with product code 51754-0105 is active and included in the NDC Directory. The product was first marketed by Exela Pharma Sciences, Llc on November 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 51754-0105-8?

    The 11-digit format is 51754010508. 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
    5-4-151754-0105-85-4-251754-0105-08