Tizanidne Hydrochloride
NDC Package 67296-1793-7

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.

Tizanidne Hydrochloride is tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Marketed by Redpharm Drug, Inc., this product is identified by NDC 67296-1793 and is authorized under FDA application ANDA212196.

Identification & Billing

NDC Package Code
67296-1793-7
Package Description
15 CAPSULE in 1 BOTTLE
Product Code
67296-1793
11-Digit Billing Format
67296179307

Clinical Specifications

Proprietary Name
Tizanidne Hydrochloride
Dosage Form
-
Usage Information
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].

Regulatory & Marketing

Labeler Name
Redpharm Drug, Inc.
FDA Application #
ANDA212196
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2019
Listing Expiration
12-31-2023
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 67296-1793-7 identifies a specific commercial package of 15 capsule in 1 bottle of Tizanidne Hydrochloride, labeled by Redpharm Drug, 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 Redpharm Drug, Inc. on March 29, 2019. The current certification is valid through December 31, 2023.

How is this Redpharm Drug, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296179307. 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 (5-4-1)
67296-1793-7
11-Digit CMS (5-4-2)
67296-1793-07

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