Amitriptyline Hydrochloride
NDC Package 69158-002-00

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.

Amitriptyline Hydrochloride is for the relief of symptoms of depression. Marketed by Glenview Pharma Inc., this product is identified by NDC 69158-002 and is authorized under FDA application ANDA085968.

Identification & Billing

NDC Package Code
69158-002-00
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
69158-002
11-Digit Billing Format
69158000200
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amitriptyline Hydrochloride
Dosage Form
-
Usage Information
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

Regulatory & Marketing

Labeler Name
Glenview Pharma Inc.
FDA Application #
ANDA085968
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-1977
Listing Expiration
12-31-2018
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 69158-002-00 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Amitriptyline Hydrochloride, labeled by Glenview 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 Glenview Pharma Inc. on November 29, 1977. The current certification is valid through December 31, 2018.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69158000200. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
69158-002-00
11-Digit CMS (5-4-2)
69158-0002-00

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