Doxepin Hydrochloride
NDC Package 49884-222-05

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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 Par Health Usa, Llc, this product is identified by NDC 49884-222 and is authorized under FDA application ANDA071422.

Identification & Billing

NDC Package Code
49884-222-05
Package Description
500 CAPSULE in 1 BOTTLE
Product Code
49884-222
11-Digit Billing Format
49884022205
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA

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
Par Health Usa, Llc
FDA Application #
ANDA071422
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-09-1987
End Marketing Date
07-14-2026
Listing Expiration
07-14-2026
Exclude Flag
D
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 (49884-222). Click a package code to view its specific billing and regulatory data.

49884-222-01
100 CAPSULE in 1 BOTTLE
49884-222-03
50 CAPSULE 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 49884-222-05 identifies a specific commercial package of 500 capsule in 1 bottle of Doxepin Hydrochloride, labeled by Par Health Usa, Llc. 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 Par Health Usa, Llc on November 09, 1987. The current certification is valid through July 14, 2026.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884022205. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
49884-222-05
11-Digit CMS (5-4-2)
49884-0222-05

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