NDC Package 57894-350-01 Simponi Aria

Golimumab Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
57894-350-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Simponi Aria
Non-Proprietary Name:
Golimumab
Substance Name:
Golimumab
Usage Information:
This medication is used to treat certain types of arthritis (such as rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis). Golimumab belongs to a class of drugs known as TNF blockers. It works by blocking a protein (tumor necrosis factor - TNF) in your body's immune system that causes joint swelling and damage. Golimumab helps slow joint damage and reduce joint pain/swelling so you can move better.
11-Digit NDC Billing Format:
57894035001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1431642 - golimumab 50 MG in 4 mL Injection
  • RxCUI: 1431642 - 4 ML golimumab 12.5 MG/ML Injection
  • RxCUI: 1431642 - golimumab 50 MG per 4 ML Injection
  • RxCUI: 1431647 - Simponi Aria 50 MG in 4 mL Injection
  • RxCUI: 1431647 - 4 ML golimumab 12.5 MG/ML Injection [Simponi]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125433
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-19-2013
    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
    57894-350-891 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-350-01?

    The NDC Packaged Code 57894-350-01 is assigned to a package of 1 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose of Simponi Aria, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 57894-350 included in the NDC Directory?

    Yes, Simponi Aria with product code 57894-350 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on July 19, 2013 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 57894-350-01?

    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 57894-350-01?

    The 11-digit format is 57894035001. 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
    5-3-257894-350-015-4-257894-0350-01