Infliximab Injection, Powder, Lyophilized, For Solution
NDC Package 71124-0004-0

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.

Infliximab injection is a medication used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Samsung Biologics Co., Ltd., this product is identified by NDC 71124-0004.

Identification & Billing

NDC Package Code
71124-0004-0
Package Description
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
71124-0004
11-Digit Billing Format
71124000400

Clinical Specifications

Proprietary Name
Infliximab
Non-Proprietary Name
Infliximab
Substance Name
Infliximab-abda
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)
INFLIXIMAB-ABDA 100 mg/1
Usage Information
This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease. This monograph is about the following infliximab products: infliximab, infliximab-abda, infliximab-axxq, and infliximab-dyyb.

Regulatory & Marketing

Labeler Name
Samsung Biologics Co., Ltd.
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
09-10-2018
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 71124-0004-0 identifies a specific commercial package of 1 injection, powder, lyophilized, for solution in 1 vial, single-dose of Infliximab (UNFINISHED drug), drug for further processing labeled by Samsung Biologics Co., Ltd.. This injection, powder, lyophilized, for solution is formulated for use and contains infliximab-abda 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 Samsung Biologics Co., Ltd. on September 10, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease. This monograph is about the following infliximab products: infliximab, infliximab-abda, infliximab-axxq, and infliximab-dyyb.

How is this Samsung Biologics Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71124000400. 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)
71124-0004-0
11-Digit CMS (5-4-2)
71124-0004-00

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