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  5. NDC Package Code: 61314-327-64 Adalimumab

NDC Package 61314-327-64 Adalimumab

Adalimumab-adaz 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:
61314-327-64
Package Description:
2 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS
Product Code:
61314-327
Proprietary Name:
Adalimumab
Non-Proprietary Name:
Adalimumab-adaz
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:
61314032764
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2641655 - adalimumab-adaz 40 MG in 0.4 ML Auto-Injector
  • RxCUI: 2641655 - 0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector
  • RxCUI: 2641655 - adalimumab-adaz 40 MG per 0.4 ML Auto-Injector
  • RxCUI: 2641660 - adalimumab-adaz 40 MG in 0.4 ML Prefilled Syringe
  • RxCUI: 2641660 - 0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz 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):
  • ADALIMUMAB 40 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:
    BLA761071
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-01-2023
    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
    61314-327-202 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61314-327-64?

    The NDC Packaged Code 61314-327-64 is assigned to a package of 2 syringe, glass in 1 carton / .4 ml in 1 syringe, glass of Adalimumab, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 61314-327 included in the NDC Directory?

    Yes, Adalimumab with product code 61314-327 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc. on July 01, 2023 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 61314-327-64?

    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 61314-327-64?

    The 11-digit format is 61314032764. 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
    5-3-261314-327-645-4-261314-0327-64