Zanaflex Capsule
NDC Package 70515-604-15

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

Package Information

Zanaflex (tizanidine hydrochloride) capsules is a medication used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury). This formulation utilizes a capsule delivery system. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-604 and is authorized under FDA application NDA021447.

Identification & Billing

NDC Package Code
70515-604-15
Package Description
150 CAPSULE in 1 BOTTLE
Product Code
70515-604
11-Digit Billing Format
70515060415
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
150 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zanaflex
Non-Proprietary Name
Tizanidine Hydrochloride
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 4 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury). It works by helping to relax the muscles.

Regulatory & Marketing

Labeler Name
Covis Pharma Us, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA021447
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2018
Listing Expiration
12-31-2026
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 70515-604-15 identifies a specific commercial package of 150 capsule in 1 bottle of Zanaflex, a human prescription drug labeled by Covis Pharma Us, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 150 billable units per package. 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 Covis Pharma Us, Inc on August 01, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury). It works by helping to relax the muscles.

How is this Covis Pharma Us, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70515060415. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 150 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)
70515-604-15
11-Digit CMS (5-4-2)
70515-0604-15

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