Zyvox Injection, Solution
NDC Package 66298-5140-1

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

Package Information

Zyvox (linezolid) injection is linezolid is an antibiotic used to treat certain serious bacterial infections. This formulation utilizes a injection, solution delivery system. Marketed by Hp Halden Pharma As, this product is identified by NDC 66298-5140 and is authorized under FDA application NDA021131.

Identification & Billing

NDC Package Code
66298-5140-1
Package Description
300 mL in 1 BAG
Product Code
66298-5140
11-Digit Billing Format
66298514001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zyvox
Non-Proprietary Name
Linezolid
Substance Name
Linezolid
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LINEZOLID 600 mg/300mL
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
Hp Halden Pharma As
Product Type
Human Prescription Drug
FDA Application #
NDA021131
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-05-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66298-5140-1 identifies a specific commercial package of 300 ml in 1 bag of Zyvox, a human prescription drug labeled by Hp Halden Pharma As. This injection, solution is formulated for intravenous 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 Hp Halden Pharma As on June 05, 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 Hp Halden Pharma As product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66298514001. 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)
66298-5140-1
11-Digit CMS (5-4-2)
66298-5140-01

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