1. Home
  2. Labeler Index
  3. Fresenius Kabi Usa, Llc
  4. 65219-612
  5. NDC Package Code: 65219-612-99 Adalimumab-aacf

NDC Package 65219-612-99 Adalimumab-aacf

Adalimumab Kit 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:
65219-612-99
Package Description:
1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)
Product Code:
65219-612
Proprietary Name:
Adalimumab-aacf
Non-Proprietary 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:
65219061299
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2640859 - adalimumab-aacf 40 MG in 0.8 ML Auto-Injector
  • RxCUI: 2640859 - 0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector
  • RxCUI: 2640859 - adalimumab-aacf 40 MG per 0.8 ML Auto-Injector
  • RxCUI: 797544 - isopropyl alcohol 70 % Medicated Pad
  • RxCUI: 797544 - isopropyl alcohol 0.7 ML/ML Medicated Pad
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Sample Package:
    No
    FDA Application Number:
    BLA761255
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-06-2023
    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.

    Frequently Asked Questions

    What is NDC 65219-612-99?

    The NDC Packaged Code 65219-612-99 is assigned to a package of 1 kit in 1 carton * .8 ml in 1 syringe, glass (65219-610-02) * 1 swab in 1 pouch (65219-332-95) of Adalimumab-aacf, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is kit and is administered via subcutaneous form.

    Is NDC 65219-612 included in the NDC Directory?

    Yes, Adalimumab-aacf with product code 65219-612 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on December 06, 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 65219-612-99?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 65219-612-99?

    The 11-digit format is 65219061299. 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
    5-3-265219-612-995-4-265219-0612-99