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  5. NDC Package Code: 55513-411-01 Amjevita

NDC Package 55513-411-01 Amjevita

Adalimumab-atto Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
55513-411-01
Package Description:
1 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE
Product Code:
55513-411
Proprietary Name:
Amjevita
Non-Proprietary Name:
Adalimumab-atto
Substance Name:
Adalimumab
Usage Information:
Adalimumab is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, ankylosing spondylitis). This medication is also used to treat certain skin disorders (such as plaque-type psoriasis, hidradenitis suppurativa). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage in arthritis as well as red scaly patches in psoriasis. Adalimumab belongs to a class of drugs known as TNF blockers. By reducing joint swelling, this medication helps to reduce further joint damage and preserve joint function. Adalimumab is also used to treat certain bowel conditions (Crohn's disease, ulcerative colitis) and a certain eye disease (uveitis).
11-Digit NDC Billing Format:
55513041101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2627711 - adalimumab-atto 20 MG in 0.4 ML Prefilled Syringe
  • RxCUI: 2627711 - 0.4 ML adalimumab-atto 50 MG/ML Prefilled Syringe
  • RxCUI: 2627711 - adalimumab-atto 20 MG per 0.4 ML Prefilled Syringe
  • RxCUI: 2627717 - AMJEVITA 20 MG in 0.4 ML Prefilled Syringe
  • RxCUI: 2627717 - 0.4 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amgen 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):
  • ADALIMUMAB 20 mg/.4mL
    • Pharmacologic Class(es):
  • Antibodies, Monoclonal - [CS]
  • Tumor Necrosis Factor Blocker - [EPC] (Established Pharmacologic Class)
  • Tumor Necrosis Factor Receptor Blocking Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761024
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    01-31-2023
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 55513-411-01?

    The NDC Packaged Code 55513-411-01 is assigned to a package of 1 syringe in 1 carton / .4 ml in 1 syringe of Amjevita, a human prescription drug labeled by Amgen Inc. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 55513-411 included in the NDC Directory?

    Yes, Amjevita with product code 55513-411 is active and included in the NDC Directory. The product was first marketed by Amgen Inc on January 31, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 55513-411-01?

    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 55513-411-01?

    The 11-digit format is 55513041101. 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
    5-3-255513-411-015-4-255513-0411-01