Glatiramer Acetate Injection, Solution
NDC Package 11797-765-03

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

Package Information

Glatiramer Acetate injection is a medication used to treat multiple sclerosis (MS). This formulation utilizes a injection, solution delivery system. Marketed by Italfarmaco Spa, this product is identified by NDC 11797-765 and is authorized under FDA application ANDA208468.

Identification & Billing

NDC Package Code
11797-765-03
Package Description
12 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
11797-765
11-Digit Billing Format
11797076503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glatiramer Acetate
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
Italfarmaco Spa
Product Type
Human Prescription Drug
FDA Application #
ANDA208468
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-10-2025
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 11797-765-03 identifies a specific commercial package of 12 syringe in 1 carton / 1 ml in 1 syringe of Glatiramer Acetate, a human prescription drug labeled by Italfarmaco Spa. 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 Italfarmaco Spa on November 10, 2025. 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 Italfarmaco Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11797076503. 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)
11797-765-03
11-Digit CMS (5-4-2)
11797-0765-03

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