Acetylcysteine Injection
NDC Package 14445-412-04

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

Package Information

Acetylcysteine injection 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 injection delivery system. Marketed by Indoco Remedies Limited, this product is identified by NDC 14445-412 and is authorized under FDA application ANDA215620.

Identification & Billing

NDC Package Code
14445-412-04
Package Description
4 VIAL in 1 CARTON / 30 mL in 1 VIAL (14445-412-30)
Product Code
14445-412
11-Digit Billing Format
14445041204
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetylcysteine
Non-Proprietary Name
Acetylcysteine
Substance Name
Acetylcysteine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ACETYLCYSTEINE 200 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
Indoco Remedies Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215620
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2022
Listing Expiration
12-31-2026
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 14445-412-04 identifies a specific commercial package of 4 vial in 1 carton / 30 ml in 1 vial (14445-412-30) of Acetylcysteine, a human prescription drug labeled by Indoco Remedies Limited. This injection is formulated for intravenous 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 Indoco Remedies Limited on March 01, 2022. The current certification is valid through December 31, 2026.

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 Indoco Remedies Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14445041204. 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 (5-3-2)
14445-412-04
11-Digit CMS (5-4-2)
14445-0412-04

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