Remeronsoltab Tablet, Orally Disintegrating
NDC Package 78206-159-01

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

Package Information

Remeronsoltab (mirtazapine) tablets is mirtazapine is used to treat depression. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-159 and is authorized under FDA application NDA021208.

Identification & Billing

NDC Package Code
78206-159-01
Package Description
5 BLISTER PACK in 1 BOX / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-159-99)
Product Code
78206-159
11-Digit Billing Format
78206015901
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
Remeronsoltab
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 45 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
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021208
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
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 78206-159-01 identifies a specific commercial package of 5 blister pack in 1 box / 6 tablet, orally disintegrating in 1 blister pack (78206-159-99) of Remeronsoltab, a human prescription drug labeled by Organon Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. 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 Organon Llc on June 01, 2021. 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 Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206015901. 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)
78206-159-01
11-Digit CMS (5-4-2)
78206-0159-01

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