Mirtazapine
NDC Package 68382-679-84

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.

Mirtazapine is used to treat depression. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-679 and is authorized under FDA application ANDA205798.

Identification & Billing

NDC Package Code
68382-679-84
Package Description
30 TABLET, ORALLY DISINTEGRATING in 1 CARTON
Product Code
68382-679
11-Digit Billing Format
68382067984

Clinical Specifications

Proprietary Name
Mirtazapine
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
Zydus Pharmaceuticals (usa) Inc.
FDA Application #
ANDA205798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-20-2017
End Marketing Date
02-02-2022
Listing Expiration
02-02-2022
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 68382-679-84 identifies a specific commercial package of 30 tablet, orally disintegrating in 1 carton of Mirtazapine, labeled by Zydus Pharmaceuticals (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 Zydus Pharmaceuticals (usa) Inc. on July 20, 2017. The current certification is valid through February 02, 2022.

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 Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382067984. 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)
68382-679-84
11-Digit CMS (5-4-2)
68382-0679-84

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