Eszopiclone
NDC Package 50436-5539-1

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Eszopiclone is a medication used to treat a certain sleep problem (insomnia). Marketed by Unit Dose Services, this product is identified by NDC 50436-5539 and is authorized under FDA application ANDA091169.

Identification & Billing

NDC Package Code
50436-5539-1
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
50436-5539
11-Digit Billing Format
50436553901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eszopiclone
Dosage Form
-
Usage Information
This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Eszopiclone belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA091169
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2014
Listing Expiration
12-31-2020
Exclude Flag
I
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 50436-5539-1 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Eszopiclone, labeled by Unit Dose Services. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Unit Dose Services on April 14, 2014. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Eszopiclone belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436553901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
50436-5539-1
11-Digit CMS (5-4-2)
50436-5539-01

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