Mirtazapine Tablet, Film Coated
NDC Package 67046-0484-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Mirtazapine tablets is mirtazapine is used to treat depression. This formulation utilizes a tablet, film coated delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0484 and is authorized under FDA application ANDA076921.

Identification & Billing

NDC Package Code
67046-0484-3
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
67046-0484
11-Digit Billing Format
67046048403
RxNorm Crosswalk
RxCUI: 314111 - mirtazapine 30 MG Oral Tablet

Clinical Specifications

Proprietary Name
Mirtazapine
Non-Proprietary Name
Mirtazapine
Substance Name
Mirtazapine
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)
MIRTAZAPINE 30 mg/1
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
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-06-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-0484-3 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Mirtazapine, a human prescription drug labeled by Coupler Llc. This tablet, film coated is formulated for oral use and contains mirtazapine 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 Coupler Llc on May 06, 2026. The current certification is valid through December 31, 2027.

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 Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046048403. 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)
67046-0484-3
11-Digit CMS (5-4-2)
67046-0484-03

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