Mirtazapine
NDC Package 0555-7243-71
Package Information
Mirtazapine is used to treat depression. Marketed by Barr Laboratories Inc., this product is identified by NDC 0555-7243 and is authorized under FDA application ANDA076307.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0555 - Barr Laboratories Inc.
- 0555-7243 - Mirtazapine
- 0555-7243-71 - 30 TABLET in 1 BLISTER PACK
- 0555-7243 - Mirtazapine
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0555-7243-71 identifies a specific commercial package of 30 tablet in 1 blister pack of Mirtazapine, labeled by Barr Laboratories Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Barr Laboratories Inc. on March 22, 2006. The current certification is valid through January 31, 2008.
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 Barr Laboratories Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00555724371. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.