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  5. NDC Package Code: 57894-070-90 Simponi

NDC Package 57894-070-90 Simponi

Golimumab Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
57894-070-90
Package Description:
1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
Product Code:
57894-070
Proprietary Name:
Simponi
Non-Proprietary Name:
Golimumab
Substance Name:
Golimumab
Usage Information:
This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage. By reducing joint swelling, the medication helps to reduce further joint damage and preserve joint function. Depending on the type of arthritis that is being treated, this drug may be used alone or in combination with another drug called methotrexate. This medication is also used to treat a certain bowel condition (ulcerative colitis). It is used to help lessen symptoms of moderate to severe ulcerative colitis (such as abdominal pain/cramping, diarrhea, bloody stools).
11-Digit NDC Billing Format:
57894007090
NDC to RxNorm Crosswalk:
  • RxCUI: 1482813 - golimumab 100 MG in 1 ML Prefilled Syringe
  • RxCUI: 1482813 - 1 ML golimumab 100 MG/ML Prefilled Syringe
  • RxCUI: 1482813 - golimumab 100 MG per 1 ML Prefilled Syringe
  • RxCUI: 1482814 - Simponi 100 MG in 1 mL Prefilled Syringe
  • RxCUI: 1482814 - 1 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, Inc.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • GOLIMUMAB 50 mg/.5mL
    • Pharmacologic Class(es):
  • Tumor Necrosis Factor Blocker - [EPC] (Established Pharmacologic Class)
  • Tumor Necrosis Factor Receptor Blocking Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA125289
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-25-2009
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    57894-070-011 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
    57894-070-021 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE
    57894-070-891 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-070-90?

    The NDC Packaged Code 57894-070-90 is assigned to a package of 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass of Simponi, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 57894-070 included in the NDC Directory?

    Yes, Simponi with product code 57894-070 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on April 25, 2009 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 11-digit format for NDC 57894-070-90?

    The 11-digit format is 57894007090. 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
    5-3-257894-070-905-4-257894-0070-90