Tizanidine
NDC Package 53217-211-04

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tizanidine is tablets, USP is a central alpha-2-adrenergic agonist indicated for themanagement of spasticity. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 53217-211 and is authorized under FDA application ANDA076416.

Identification & Billing

NDC Package Code
53217-211-04
Package Description
240 TABLET in 1 BOTTLE
Product Code
53217-211
11-Digit Billing Format
53217021104
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
240 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tizanidine
Dosage Form
-
Usage Information
TizanidineTablets, USP is a central alpha-2-adrenergic agonist indicated for themanagement of spasticity. Because of the short duration of therapeutic effect,treatment with Tizanidine Tablets, USP should be reserved for those dailyactivities and times when relief of spasticity is most important [see Dosage andAdministration(2.1)].

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA076416
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-11-2003
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53217-211). Click a package code to view its specific billing and regulatory data.

53217-211-02
120 TABLET in 1 BOTTLE
53217-211-15
15 TABLET in 1 BOTTLE
53217-211-30
150 TABLET in 1 BOTTLE
53217-211-60
60 TABLET in 1 BOTTLE
53217-211-90
90 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 53217-211-04 identifies a specific commercial package of 240 tablet in 1 bottle of Tizanidine, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 240 billable units per package. 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 Aidarex Pharmaceuticals Llc on December 11, 2003. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53217021104. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 240 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)
53217-211-04
11-Digit CMS (5-4-2)
53217-0211-04

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