Mirtazapine Tablet, Orally Disintegrating
NDC Package 72578-103-84

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, orally disintegrating delivery system. Marketed by Viona Pharmaceuticals Inc., this product is identified by NDC 72578-103 and is authorized under FDA application ANDA205798.

Identification & Billing

NDC Package Code
72578-103-84
Package Description
5 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)
Product Code
72578-103
11-Digit Billing Format
72578010384
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mirtazapine
Non-Proprietary Name
Mirtazapine
Substance Name
Mirtazapine
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIRTAZAPINE 15 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
Viona Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-07-2022
Listing Expiration
12-31-2026
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 72578-103-84 identifies a specific commercial package of 5 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack (72578-103-69) of Mirtazapine, a human prescription drug labeled by Viona Pharmaceuticals Inc.. This tablet, orally disintegrating 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 Viona Pharmaceuticals Inc. on August 07, 2022. The current certification is valid through December 31, 2026.

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 Viona Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72578010384. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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)
72578-103-84
11-Digit CMS (5-4-2)
72578-0103-84

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