Zymfentra Injection
NDC Package 72606-047-01

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

Package Information

Zymfentra (infliximab-dyyb) 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 delivery system. Marketed by Celltrion Usa Inc., this product is identified by NDC 72606-047 and is authorized under FDA application BLA761358.

Identification & Billing

NDC Package Code
72606-047-01
Package Description
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
72606-047
11-Digit Billing Format
72606004701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zymfentra
Non-Proprietary Name
Infliximab-dyyb
Substance Name
Infliximab-dyyb
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
INFLIXIMAB-DYYB 120 mg/mL
Pharmacologic Class
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
Celltrion Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761358
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 72606-047-01 identifies a specific commercial package of 1 syringe in 1 carton / 1 ml in 1 syringe of Zymfentra, a human prescription drug labeled by Celltrion Usa Inc.. This injection is formulated for subcutaneous use and contains infliximab-dyyb 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 Celltrion Usa Inc. on March 01, 2024. 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 Celltrion Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72606004701. 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)
72606-047-01
11-Digit CMS (5-4-2)
72606-0047-01

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