Linezolid
NDC Package 32228-003-08
Package Information
Linezolid is an antibiotic used to treat certain serious bacterial infections. Marketed by Celltrion, Inc., this product is identified by NDC 32228-003 and is authorized under FDA application ANDA210702.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 32228 - Celltrion, Inc.
- 32228-003 - Linezolid
- 32228-003-08 - 30 TABLET in 1 PACKAGE
- 32228-003 - Linezolid
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 (32228-003). Click a package code to view its specific billing and regulatory data.
* 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 32228-003-08 identifies a specific commercial package of 30 tablet in 1 package of Linezolid, labeled by Celltrion, 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 Celltrion, Inc. on April 25, 2019. The current certification is valid through October 04, 2019.
What are the primary indications for this medication?
Linezolid is an antibiotic used to treat certain serious bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Linezolid also belongs to a class of drugs known as MAO inhibitors. It can increase the levels of certain natural substances in the body (such as dopamine, norepinephrine, serotonin) which can increase the chance of certain side effects and food and drug interactions. See How to Use, Side Effects, and Drug Interactions sections for more details.
How is this Celltrion, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 32228000308. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
