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  5. NDC Package Code: 57894-640-01 Tremfya

NDC Package 57894-640-01 Tremfya

Guselkumab Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
57894-640-01
Package Description:
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code:
57894-640
Proprietary Name:
Tremfya
Non-Proprietary Name:
Guselkumab
Substance Name:
Guselkumab
Usage Information:
This medication is used to treat plaque psoriasis and psoriatic arthritis. Guselkumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural substance in your body (interleukin-23) that may cause inflammation and swelling. Guselkumab can help lessen the red, scaly, itchy patches of skin caused by plaque psoriasis and lessen the pain and swelling in the joints caused by psoriatic arthritis.
11-Digit NDC Billing Format:
57894064001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1928686 - guselkumab 100 MG in 1 ML Prefilled Syringe
  • RxCUI: 1928686 - 1 ML guselkumab 100 MG/ML Prefilled Syringe
  • RxCUI: 1928689 - Tremfya 100 MG in 1 ML Prefilled Syringe
  • RxCUI: 1928689 - 1 ML guselkumab 100 MG/ML Prefilled Syringe [Tremfya]
  • RxCUI: 1928689 - 1 ML Tremfya 100 MG/ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • GUSELKUMAB 100 mg/mL
    • Pharmacologic Class(es):
  • Interleukin-23 Antagonist - [EPC] (Established Pharmacologic Class)
  • Interleukin-23 Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761061
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-13-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 57894-640-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    57894064001J1628Inj., guselkumab, 1 mg1 MG11100100

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    57894-640-041 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
    57894-640-111 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
    57894-640-991 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-640-01?

    The NDC Packaged Code 57894-640-01 is assigned to a package of 1 syringe in 1 carton / 1 ml in 1 syringe of Tremfya, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 57894-640 included in the NDC Directory?

    Yes, Tremfya with product code 57894-640 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on July 13, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 57894-640-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 57894-640-01?

    The 11-digit format is 57894064001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-257894-640-015-4-257894-0640-01