NDC Package 83008-006-30 Mirtazapine

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

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:

83008-006-30

Package Description:

30 TABLET, FILM COATED in 1 BOTTLE

Product Code:

83008-006

Proprietary Name:

Mirtazapine

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:

83008000630

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to RxNorm Crosswalk:

RxCUI: 311725 - mirtazapine 15 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Quality Care Products, Llc

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

MIRTAZAPINE 15 mg/1

Sample Package:

FDA Application Number:

ANDA076921

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-11-2023

End Marketing Date:

09-30-2025

Exclude Flag:

Code Structure:

83008 - Quality Care Products, Llc
- 83008-006 - Mirtazapine
  - 83008-006-30 - 30 TABLET, FILM COATED in 1 BOTTLE

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
83008-006-60	60 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 83008-006-30?

The NDC Packaged Code 83008-006-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Mirtazapine, a human prescription drug labeled by Quality Care Products, Llc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 83008-006 included in the NDC Directory?

Yes, Mirtazapine with product code 83008-006 is active and included in the NDC Directory. The product was first marketed by Quality Care Products, Llc on April 11, 2023.

What is the NDC billing unit for package 83008-006-30?

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 30.

What is the 11-digit format for NDC 83008-006-30?

The 11-digit format is 83008000630. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	83008-006-30	5-4-2	83008-0006-30

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