Acetylcysteine
NDC Package 0517-7630-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Acetylcysteine 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). Marketed by American Regent, Inc., this product is identified by NDC 0517-7630 and is authorized under FDA application ANDA072547.

Identification & Billing

NDC Package Code
0517-7630-03
Package Description
3 VIAL, GLASS in 1 BOX / 30 mL in 1 VIAL, GLASS
Product Code
0517-7630
11-Digit Billing Format
00517763003
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetylcysteine
Dosage Form
-
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
American Regent, Inc.
FDA Application #
ANDA072547
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-1995
End Marketing Date
12-31-2016
Listing Expiration
12-31-2016
Exclude Flag
D
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 0517-7630-03 identifies a specific commercial package of 3 vial, glass in 1 box / 30 ml in 1 vial, glass of Acetylcysteine, labeled by American Regent, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by American Regent, Inc. on October 01, 1995. The current certification is valid through December 31, 2016.

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 American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517763003. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0517-7630-03
11-Digit CMS (5-4-2)
00517-7630-03

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