Etanercept, License Holder Unspecified Injection, Powder, Lyophilized, For Solution
NDC Package 63552-102-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Etanercept, License Holder Unspecified injection is a medication used alone or in combination with an immunosuppressant (such as methotrexate) to treat certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-102.

Identification & Billing

NDC Package Code
63552-102-00
Package Description
5 TRAY in 1 CASE / 221 VIAL in 1 TRAY / 2 mL in 1 VIAL
Product Code
63552-102
11-Digit Billing Format
63552010200

Clinical Specifications

Proprietary Name
Etanercept, License Holder Unspecified
Non-Proprietary Name
Etanercept, License Holder Unspecified
Substance Name
Etanercept
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Active Ingredient(s)
ETANERCEPT 25 mg/mL
Usage Information
This medication is used alone or in combination with an immunosuppressant (such as methotrexate) to treat certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis). Some brands of this medication are also used to treat a skin condition called psoriasis. These conditions are caused by an overactive immune system (autoimmune disease). The immune system attacks the body's own healthy cells, causing inflammation in the joints and skin. Etanercept controls your body's defensive response by blocking the action of a certain natural substance (TNF) that is used by the immune system. Treatment decreases redness, itching and scaly patches in psoriasis as well as the pain, swelling and stiffness of joints in arthritis. This medication can stop the progression of disease and joint damage, resulting in improved daily functioning and quality of life. This medication treats but does not cure autoimmune diseases. Symptoms usually return within 1 month of stopping the medication.

Regulatory & Marketing

Labeler Name
Patheon Manufacturing Services Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-02-2003
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63552-102-00 identifies a specific commercial package of 5 tray in 1 case / 221 vial in 1 tray / 2 ml in 1 vial of Etanercept, License Holder Unspecified (UNFINISHED drug), drug for further processing labeled by Patheon Manufacturing Services Llc. This injection, powder, lyophilized, for solution is formulated for use and contains etanercept 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 Patheon Manufacturing Services Llc on January 02, 2003. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used alone or in combination with an immunosuppressant (such as methotrexate) to treat certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis). Some brands of this medication are also used to treat a skin condition called psoriasis. These conditions are caused by an overactive immune system (autoimmune disease). The immune system attacks the body's own healthy cells, causing inflammation in the joints and skin. Etanercept controls your body's defensive response by blocking the action of a certain natural substance (TNF) that is used by the immune system. Treatment decreases redness, itching and scaly patches in psoriasis as well as the pain, swelling and stiffness of joints in arthritis. This medication can stop the progression of disease and joint damage, resulting in improved daily functioning and quality of life. This medication treats but does not cure autoimmune diseases. Symptoms usually return within 1 month of stopping the medication.

How is this Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552010200. 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)
63552-102-00
11-Digit CMS (5-4-2)
63552-0102-00

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