Tizanidine Capsule
NDC Package 72189-678-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tizanidine capsules is tizanidine hydrochloride is indicated for the treatment of spasticity in adults. This formulation utilizes a capsule delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-678 and is authorized under FDA application ANDA213798.

Identification & Billing

NDC Package Code
72189-678-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
72189-678
11-Digit Billing Format
72189067830

Clinical Specifications

Proprietary Name
Tizanidine
Non-Proprietary Name
Tizanidine
Substance Name
Tizanidine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TIZANIDINE HYDROCHLORIDE 6 mg/1
Pharmacologic Class
Usage Information
Tizanidine hydrochloride is indicated for the treatment of spasticity in adults.

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA213798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-16-2026
Listing Expiration
12-31-2027
Exclude Flag
N
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 72189-678-30 identifies a specific commercial package of 30 capsule in 1 bottle of Tizanidine, a human prescription drug labeled by Direct_rx. This capsule is formulated for oral use and contains tizanidine hydrochloride 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 Direct_rx on June 16, 2026. The current certification is valid through December 31, 2027.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189067830. 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)
72189-678-30
11-Digit CMS (5-4-2)
72189-0678-30

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