Amitryptline Hydrochloride Kit
NDC Package 76420-710-06

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Amitryptline Hydrochloride kits is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a kit delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-710.

Identification & Billing

NDC Package Code
76420-710-06
Package Description
1 KIT in 1 KIT * 58.8 g in 1 BOTTLE, PLASTIC * 1.2 g in 1 BOTTLE, PLASTIC
Product Code
76420-710
11-Digit Billing Format
76420071006
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.

Clinical Specifications

Proprietary Name
Amitryptline Hydrochloride
Non-Proprietary Name
Amitryptline Hydrochloride
Dosage Form
Kit - A packaged collection of related material.

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
09-20-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 76420-710-06 identifies a specific commercial package of 1 kit in 1 kit * 58.8 g in 1 bottle, plastic * 1.2 g in 1 bottle, plastic of Amitryptline Hydrochloride (UNFINISHED drug), a bulk ingredient labeled by Asclemed Usa, Inc.. This kit is formulated for use and contains 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 Asclemed Usa, Inc. on September 20, 2013. The current certification is valid through December 31, 2026.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420071006. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
76420-710-06
11-Digit CMS (5-4-2)
76420-0710-06

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