Estazolam
NDC Package 51862-073-01

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 discontinued by the firm.

Estazolam is a medication used to treat a certain sleep problem (insomnia). Marketed by Mayne Pharma, this product is identified by NDC 51862-073 and is authorized under FDA application ANDA074921.

Identification & Billing

NDC Package Code
51862-073-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
51862-073
11-Digit Billing Format
51862007301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Estazolam
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. Estazolam belongs to a class of drugs called benzodiazepines. 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
Mayne Pharma
FDA Application #
ANDA074921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-18-2020
End Marketing Date
02-28-2025
Listing Expiration
02-28-2025
Exclude Flag
D
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 51862-073-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Estazolam, labeled by Mayne Pharma. 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 Mayne Pharma on October 18, 2020. The current certification is valid through February 28, 2025.

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. Estazolam belongs to a class of drugs called benzodiazepines. 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 Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862007301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
51862-073-01
11-Digit CMS (5-4-2)
51862-0073-01

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