Tizanidine Hydrochloride Tablet
NDC Package 49999-347-01

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 Hydrochloride tablets is iNDICATIONS AND USAGETizanidine tablets are a short-acting drug for the management of spasticity. This formulation utilizes a tablet delivery system. Marketed by Quality Care Products Llc, this product is identified by NDC 49999-347 and is authorized under FDA application ANDA076286.

Identification & Billing

NDC Package Code
49999-347-01
Package Description
120 TABLET in 1 BOTTLE, PLASTIC
Product Code
49999-347
11-Digit Billing Format
49999034701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tizanidine Hydrochloride
Non-Proprietary Name
Tizanidine Hydrochloride
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
INDICATIONS AND USAGETizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Quality Care Products Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076286
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2010
End Marketing Date
04-30-2027
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 (49999-347). Click a package code to view its specific billing and regulatory data.

49999-347-15
15 TABLET in 1 BOTTLE, PLASTIC
49999-347-28
28 TABLET in 1 BOTTLE, PLASTIC
49999-347-30
30 TABLET in 1 BOTTLE, PLASTIC
49999-347-60
60 TABLET in 1 BOTTLE, PLASTIC
49999-347-90
90 TABLET in 1 BOTTLE, PLASTIC

* 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 49999-347-01 identifies a specific commercial package of 120 tablet in 1 bottle, plastic of Tizanidine Hydrochloride, a human prescription drug labeled by Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package. 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 Quality Care Products Llc on November 23, 2010.

How is this Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49999034701. 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:

10-Digit Format (5-3-2)
49999-347-01
11-Digit CMS (5-4-2)
49999-0347-01

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