Linezolid Powder
NDC Package 65841-166-12

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 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.

Linezolid powders is linezolid is an antibiotic used to treat certain serious bacterial infections. This formulation utilizes a powder delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-166.

Identification & Billing

NDC Package Code
65841-166-12
Package Description
1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 15 kg in 1 BAG
Product Code
65841-166
11-Digit Billing Format
65841016612

Clinical Specifications

Proprietary Name
Linezolid
Non-Proprietary Name
Linezolid
Substance Name
Linezolid
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)
LINEZOLID 1 kg/kg
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
Zydus Lifesciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-12-2018
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65841-166-12 identifies a specific commercial package of 1 pouch in 1 drum / 1 bag in 1 pouch / 1 bag in 1 bag / 1 bag in 1 bag / 15 kg in 1 bag of Linezolid (UNFINISHED drug), a bulk ingredient labeled by Zydus Lifesciences Limited. This powder is formulated for 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 Zydus Lifesciences Limited on January 12, 2018. 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 Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841016612. 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)
65841-166-12
11-Digit CMS (5-4-2)
65841-0166-12

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