Tizanidine Tablet
NDC Package 85534-0030-1

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

Package Information

Tizanidine tablets are indicated for the treatment of spasticity in adults. This formulation utilizes a tablet delivery system. Marketed by Hawaii Repack, Inc., this product is identified by NDC 85534-0030 and is authorized under FDA application ANDA076286.

Identification & Billing

NDC Package Code
85534-0030-1
Package Description
20 TABLET in 1 BOTTLE
Product Code
85534-0030
11-Digit Billing Format
85534003001

Clinical Specifications

Proprietary Name
Tizanidine
Non-Proprietary Name
Tizanidine
Substance Name
Tizanidine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TIZANIDINE HYDROCHLORIDE 4 mg/1
Pharmacologic Class
Usage Information
Tizanidine tablets are indicated for the treatment of spasticity in adults.

Regulatory & Marketing

Labeler Name
Hawaii Repack, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076286
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-03-2002
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (85534-0030). Click a package code to view its specific billing and regulatory data.

85534-0030-0
10 TABLET in 1 BOTTLE
85534-0030-2
30 TABLET in 1 BOTTLE
85534-0030-3
60 TABLET in 1 BOTTLE
85534-0030-4
90 TABLET in 1 BOTTLE
85534-0030-5
120 TABLET in 1 BOTTLE

* 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 85534-0030-1 identifies a specific commercial package of 20 tablet in 1 bottle of Tizanidine, a human prescription drug labeled by Hawaii Repack, Inc.. This tablet 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 Hawaii Repack, Inc. on July 03, 2002. The current certification is valid through December 31, 2027.

How is this Hawaii Repack, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85534003001. 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)
85534-0030-1
11-Digit CMS (5-4-2)
85534-0030-01

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