Tizanidine
NDC Package 16590-221-72
Package Information
Tizanidine is iNDICATIONS AND USAGETizanidine tablets are a short-acting drug for the management of spasticity. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-221 and is authorized under FDA application ANDA076286.
Identification & Billing
- RxCUI: 313412 - tiZANidine HCl 2 MG Oral Tablet
- RxCUI: 313412 - tizanidine 2 MG Oral Tablet
- RxCUI: 313412 - tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet
- RxCUI: 313413 - tiZANidine HCl 4 MG Oral Tablet
- RxCUI: 313413 - tizanidine 4 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 16590 - Stat Rx Usa Llc
- 16590-221 - Tizanidine
- 16590-221-72 - 120 TABLET in 1 BOTTLE
- 16590-221 - Tizanidine
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 (16590-221). Click a package code to view its specific billing and regulatory data.
* 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 16590-221-72 identifies a specific commercial package of 120 tablet in 1 bottle of Tizanidine, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 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 Stat Rx Usa Llc on July 03, 2002. The current certification is valid through December 31, 2017.
How is this Stat Rx Usa Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590022172. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
