Acetylcysteine Powder
NDC Package 49452-0098-2

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Acetylcysteine powders 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 powder delivery system. Marketed by Spectrum Laboratory Products, Inc., this product is identified by NDC 49452-0098.

Identification & Billing

NDC Package Code
49452-0098-2
Package Description
.1 kg in 1 BOTTLE, PLASTIC
Product Code
49452-0098
11-Digit Billing Format
49452009802
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100.0 GM

Clinical Specifications

Proprietary Name
Acetylcysteine
Non-Proprietary Name
Acetylcysteine
Substance Name
Acetylcysteine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ACETYLCYSTEINE 1 kg/kg
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
Spectrum Laboratory Products, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
03-01-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49452-0098). Click a package code to view its specific billing and regulatory data.

49452-0098-1
.025 kg in 1 BOTTLE, PLASTIC
49452-0098-3
.5 kg in 1 CONTAINER
49452-0098-4
1 kg in 1 CONTAINER
49452-0098-5
5 kg in 1 PAIL

* 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 49452-0098-2 identifies a specific commercial package of .1 kg in 1 bottle, plastic of Acetylcysteine (UNFINISHED drug), a bulk ingredient labeled by Spectrum Laboratory Products, Inc.. This product is billed per "GM" gram and contains an estimated amount of 100.0 billable units per package. This powder is formulated for 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 Spectrum Laboratory Products, Inc. on March 01, 2020. 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 Spectrum Laboratory Products, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49452009802. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100.0 total billable units per package. 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)
49452-0098-2
11-Digit CMS (5-4-2)
49452-0098-02

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