NDC Package 78206-158-01 Remeronsoltab

Mirtazapine Tablet, Orally Disintegrating Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
78206-158-01
Package Description:
5 BLISTER PACK in 1 BOX / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-158-99)
Product Code:
Proprietary Name:
Remeronsoltab
Non-Proprietary Name:
Mirtazapine
Substance Name:
Mirtazapine
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.
11-Digit NDC Billing Format:
78206015801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
5 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 211322 - Remeron 15 MG Oral Tablet
  • RxCUI: 211322 - mirtazapine 15 MG Oral Tablet [Remeron]
  • RxCUI: 211323 - Remeron 30 MG Oral Tablet
  • RxCUI: 211323 - mirtazapine 30 MG Oral Tablet [Remeron]
  • RxCUI: 283406 - mirtazapine 15 MG Disintegrating Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Organon Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA021208
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2021
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 78206-158-01?

    The NDC Packaged Code 78206-158-01 is assigned to a package of 5 blister pack in 1 box / 6 tablet, orally disintegrating in 1 blister pack (78206-158-99) of Remeronsoltab, a human prescription drug labeled by Organon Llc. The product's dosage form is tablet, orally disintegrating and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package.

    Is NDC 78206-158 included in the NDC Directory?

    Yes, Remeronsoltab with product code 78206-158 is active and included in the NDC Directory. The product was first marketed by Organon Llc on June 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 78206-158-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 5.

    What is the 11-digit format for NDC 78206-158-01?

    The 11-digit format is 78206015801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-278206-158-015-4-278206-0158-01