Idacio Kit
NDC Package 65219-558-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Idacio (adalimumab-aacf) kits is none. This formulation utilizes a kit delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 65219-558 and is authorized under FDA application BLA761255.

Identification & Billing

NDC Package Code
65219-558-08
Package Description
1 KIT in 1 CARTON * .8 mL in 1 VIAL, GLASS (65219-562-01) * 1 SWAB in 1 POUCH (65219-332-95)
Product Code
65219-558
11-Digit Billing Format
65219055808
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Idacio
Non-Proprietary Name
Adalimumab-aacf
Dosage Form
Kit - A packaged collection of related material.
Usage Information
None.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761255
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-09-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65219-558-08 identifies a specific commercial package of 1 kit in 1 carton * .8 ml in 1 vial, glass (65219-562-01) * 1 swab in 1 pouch (65219-332-95) of Idacio, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on December 09, 2024. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65219055808. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65219-558-08
11-Digit CMS (5-4-2)
65219-0558-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.