Linezolid Tablet, Coated
NDC Package 33342-352-11

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

Linezolid tablets is linezolid is an antibiotic used to treat certain serious bacterial infections. This formulation utilizes a tablet, coated delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-352 and is authorized under FDA application ANDA210378.

Identification & Billing

NDC Package Code
33342-352-11
Package Description
100 TABLET, COATED in 1 BOTTLE
Product Code
33342-352
11-Digit Billing Format
33342035211
RxNorm Crosswalk
RxCUI: 311347 - linezolid 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Linezolid
Non-Proprietary Name
Linezolid
Substance Name
Linezolid
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LINEZOLID 600 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210378
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-10-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-352). Click a package code to view its specific billing and regulatory data.

33342-352-31
5 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK
33342-352-32
20 TABLET, COATED in 1 BOTTLE

* 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 33342-352-11 identifies a specific commercial package of 100 tablet, coated in 1 bottle of Linezolid, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet, coated is formulated for oral use and contains linezolid 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 Macleods Pharmaceuticals Limited on October 10, 2024. The current certification is valid through December 31, 2026.

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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342035211. 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)
33342-352-11
11-Digit CMS (5-4-2)
33342-0352-11

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