Doxepin Hydrochloride Tablet
NDC Package 44183-103-30

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

Package Information

Doxepin Hydrochloride tablets is doxepin HCl Tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. This formulation utilizes a tablet delivery system. Marketed by Currax Pharmaceuticals Llc Dba Cypress, Hawthorn, Macoven, this product is identified by NDC 44183-103 and is authorized under FDA application NDA022036.

Identification & Billing

NDC Package Code
44183-103-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
44183-103
11-Digit Billing Format
44183010330
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
Doxepin Hydrochloride
Non-Proprietary Name
Doxepin Hydrochloride
Substance Name
Doxepin Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXEPIN HYDROCHLORIDE 3 mg/1
Pharmacologic Class
Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
Usage Information
Doxepin HCl Tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Currax Pharmaceuticals Llc Dba Cypress, Hawthorn, Macoven
Product Type
Human Prescription Drug
FDA Application #
NDA022036
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
08-01-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 44183-103-30 identifies a specific commercial package of 30 tablet in 1 bottle of Doxepin Hydrochloride, a human prescription drug labeled by Currax Pharmaceuticals Llc Dba Cypress, Hawthorn, Macoven. This tablet is formulated for oral use and contains doxepin hydrochloride 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 Currax Pharmaceuticals Llc Dba Cypress, Hawthorn, Macoven on August 01, 2010. The current certification is valid through December 31, 2026.

How is this Currax Pharmaceuticals Llc Dba Cypress, Hawthorn, Macoven product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44183010330. 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)
44183-103-30
11-Digit CMS (5-4-2)
44183-0103-30

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