Tizanidine Hydrochloride
NDC Package 75834-209-15

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.

Tizanidine Hydrochloride is tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-209 and is authorized under FDA application ANDA210021.

Identification & Billing

NDC Package Code
75834-209-15
Package Description
150 CAPSULE in 1 BOTTLE
Product Code
75834-209
11-Digit Billing Format
75834020915
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
150 EA

Clinical Specifications

Proprietary Name
Tizanidine Hydrochloride
Dosage Form
-
Usage Information
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine 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
Nivagen Pharmaceuticals, Inc.
FDA Application #
ANDA210021
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-26-2019
End Marketing Date
08-26-2026
Listing Expiration
08-26-2026
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 75834-209-15 identifies a specific commercial package of 150 capsule in 1 bottle of Tizanidine Hydrochloride, labeled by Nivagen Pharmaceuticals, 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 Nivagen Pharmaceuticals, Inc. on September 26, 2019. The current certification is valid through August 26, 2026.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834020915. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 150 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)
75834-209-15
11-Digit CMS (5-4-2)
75834-0209-15

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