Doxepin Hydrochloride
NDC Package 45865-968-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Doxepin Hydrochloride is doxepin HCl is recommended for the treatment of:•Psychoneurotic patients with depression and/or anxiety.•Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).•Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).•Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.The target symptoms of psychoneurosis that respond particularly well to doxepin HCl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.Clinical experience has shown that doxepin HCl is safe and well tolerated even in the elderly patient. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-968 and is authorized under FDA application ANDA071422.

Identification & Billing

NDC Package Code
45865-968-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
45865-968
11-Digit Billing Format
45865096830
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Doxepin Hydrochloride
Dosage Form
-
Usage Information
Doxepin HCl is recommended for the treatment of:•Psychoneurotic patients with depression and/or anxiety.•Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).•Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).•Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.The target symptoms of psychoneurosis that respond particularly well to doxepin HCl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.Clinical experience has shown that doxepin HCl is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin HCl is not recommended for use in children under 12 years of age.

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
ANDA071422
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2017
Listing Expiration
12-31-2024
Exclude Flag
I
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 45865-968-30 identifies a specific commercial package of 30 capsule in 1 bottle of Doxepin Hydrochloride, labeled by Medsource Pharmaceuticals. 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 Medsource Pharmaceuticals on September 01, 2017. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865096830. 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)
45865-968-30
11-Digit CMS (5-4-2)
45865-0968-30

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