Mirtazapine Tablet, Film Coated
NDC Package 57237-009-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Rising Pharma Holdings, Inc., this product is identified by NDC 57237-009 and is authorized under FDA application ANDA076921.

Identification & Billing

NDC Package Code
57237-009-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
57237-009
11-Digit Billing Format
57237000930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

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
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-22-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57237-009). Click a package code to view its specific billing and regulatory data.

57237-009-05
500 TABLET, FILM COATED in 1 BOTTLE

* 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 57237-009-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Mirtazapine, a human prescription drug labeled by Rising Pharma Holdings, Inc.. 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 Rising Pharma Holdings, Inc. on October 22, 2004. 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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237000930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
57237-009-30
11-Digit CMS (5-4-2)
57237-0009-30

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