Doxepin Hydrochloride
NDC Package 40085-716-45

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 discontinued by the firm.

Doxepin Hydrochloride is a . Marketed by Renaissance Pharma, Inc., this product is identified by NDC 40085-716 and is authorized under FDA application NDA020126.

Identification & Billing

NDC Package Code
40085-716-45
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
40085-716
11-Digit Billing Format
40085071645
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM

Clinical Specifications

Proprietary Name
Doxepin Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Renaissance Pharma, Inc.
FDA Application #
NDA020126
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
03-07-2016
End Marketing Date
12-31-2019
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 40085-716-45 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Doxepin Hydrochloride, labeled by Renaissance Pharma, Inc.. 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 Renaissance Pharma, Inc. on March 07, 2016. The current certification is valid through December 31, 2019.

How is this Renaissance Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40085071645. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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)
40085-716-45
11-Digit CMS (5-4-2)
40085-0716-45

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