Copaxone Injection, Solution
NDC Package 68546-325-06

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

Copaxone (glatiramer acetate) injection is a medication used to treat multiple sclerosis (MS). This formulation utilizes a injection, solution delivery system. Marketed by Teva Neuroscience, Inc., this product is identified by NDC 68546-325 and is authorized under FDA application NDA020622.

Identification & Billing

NDC Package Code
68546-325-06
Package Description
6 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Product Code
68546-325
11-Digit Billing Format
68546032506
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Copaxone
Non-Proprietary Name
Glatiramer Acetate
Substance Name
Glatiramer Acetate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
GLATIRAMER ACETATE 40 mg/mL
Usage Information
This medication is used to treat multiple sclerosis (MS). It is a protein that is thought to work by preventing your immune system from attacking the nerves in your brain and spinal cord. This effect can decrease the number of periods of disease worsening (relapses) and prevent or delay disability. It is not a cure for MS.

Regulatory & Marketing

Labeler Name
Teva Neuroscience, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020622
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-29-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68546-325). Click a package code to view its specific billing and regulatory data.

68546-325-12
12 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

* 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 68546-325-06 identifies a specific commercial package of 6 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 ml in 1 syringe, glass of Copaxone, a human prescription drug labeled by Teva Neuroscience, Inc.. This injection, solution is formulated for subcutaneous use and contains glatiramer acetate 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 Teva Neuroscience, Inc. on January 29, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat multiple sclerosis (MS). It is a protein that is thought to work by preventing your immune system from attacking the nerves in your brain and spinal cord. This effect can decrease the number of periods of disease worsening (relapses) and prevent or delay disability. It is not a cure for MS.

How is this Teva Neuroscience, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68546032506. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
68546-325-06
11-Digit CMS (5-4-2)
68546-0325-06

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