Acetylcysteine Inhalant
NDC Package 55154-5730-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Acetylcysteine inhalants is 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 formulation utilizes a inhalant delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-5730 and is authorized under FDA application ANDA072489.

Identification & Billing

NDC Package Code
55154-5730-5
Package Description
5 VIAL, GLASS in 1 BAG / 4 mL in 1 VIAL, GLASS
Product Code
55154-5730
11-Digit Billing Format
55154573005
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetylcysteine
Non-Proprietary Name
Acetylcysteine
Substance Name
Acetylcysteine
Dosage Form
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
ACETYLCYSTEINE 100 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA072489
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-06-2011
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55154-5730-5 identifies a specific commercial package of 5 vial, glass in 1 bag / 4 ml in 1 vial, glass of Acetylcysteine, a human prescription drug labeled by Cardinal Health 107, Llc. This inhalant is formulated for respiratory (inhalation) use and contains acetylcysteine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cardinal Health 107, Llc on May 06, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154573005. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
55154-5730-5
11-Digit CMS (5-4-2)
55154-5730-05

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.