Linezolid Tablet, Film Coated
NDC Package 59762-1307-2

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Linezolid tablets is linezolid is an antibiotic used to treat certain serious bacterial infections. This formulation utilizes a tablet, film coated delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 59762-1307 and is authorized under FDA application NDA021130.

Identification & Billing

NDC Package Code
59762-1307-2
Package Description
20 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
59762-1307
11-Digit Billing Format
59762130702
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
RxNorm Crosswalk
RxCUI: 311347 - linezolid 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Linezolid
Non-Proprietary Name
Linezolid
Substance Name
Linezolid
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021130
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-12-2015
End Marketing Date
08-31-2026
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 (59762-1307). Click a package code to view its specific billing and regulatory data.

59762-1307-1
20 TABLET, FILM 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 59762-1307-2 identifies a specific commercial package of 20 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack of Linezolid, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet, film 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 Mylan Pharmaceuticals Inc. on October 12, 2015.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59762130702. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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)
59762-1307-2
11-Digit CMS (5-4-2)
59762-1307-02

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