Glatopa Injection, Solution
NDC Package 63629-8816-1

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

Package Information

Glatopa (glatiramer acetate) injection is a medication used to treat multiple sclerosis (MS). This formulation utilizes a injection, solution delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-8816 and is authorized under FDA application ANDA206921.

Identification & Billing

NDC Package Code
63629-8816-1
Package Description
12 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Product Code
63629-8816
11-Digit Billing Format
63629881601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glatopa
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
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA206921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2018
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 63629-8816-1 identifies a specific commercial package of 12 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 ml in 1 syringe, glass of Glatopa, a human prescription drug labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on February 12, 2018. 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 Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629881601. 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 (5-4-1)
63629-8816-1
11-Digit CMS (5-4-2)
63629-8816-01

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