Remeron
NDC Package 0052-0109-30

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.

Remeron is mirtazapine is used to treat depression. Marketed by Organon Usa Inc., this product is identified by NDC 0052-0109 and is authorized under FDA application NDA020415.

Identification & Billing

NDC Package Code
0052-0109-30
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0052-0109
11-Digit Billing Format
00052010930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Remeron
Dosage Form
-
Usage Information
Mirtazapine is used to treat depression. It improves mood and feelings of well-being. Mirtazapine is an antidepressant that works by restoring the balance of natural chemicals (neurotransmitters) in the brain.

Regulatory & Marketing

Labeler Name
Organon Usa Inc.
FDA Application #
NDA020415
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-11-1997
End Marketing Date
01-31-2018
Listing Expiration
01-31-2018
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 0052-0109-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Remeron, labeled by Organon Usa Inc.. 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 Organon Usa Inc. on March 11, 1997. The current certification is valid through January 31, 2018.

What are the primary indications for this medication?

Mirtazapine is used to treat depression. It improves mood and feelings of well-being. Mirtazapine is an antidepressant that works by restoring the balance of natural chemicals (neurotransmitters) in the brain.

How is this Organon Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00052010930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (4-4-2)
0052-0109-30
11-Digit CMS (5-4-2)
00052-0109-30

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