Cyltezo Kit
NDC Package 0597-0375-53

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

Package Information

Cyltezo (adalimumab-adbm) kits is none. This formulation utilizes a kit delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0375 and is authorized under FDA application BLA761058.

Identification & Billing

NDC Package Code
0597-0375-53
Package Description
1 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET
Product Code
0597-0375
11-Digit Billing Format
00597037553
RxNorm Crosswalk

Clinical Specifications

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

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761058
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0597-0375). Click a package code to view its specific billing and regulatory data.

0597-0375-16
6 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET
0597-0375-23
4 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET
0597-0375-48
1 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET
0597-0375-97
2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET

* 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 0597-0375-53 identifies a specific commercial package of 1 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .8 ml in 1 syringe * 2 packet in 1 tray / 1 ml in 1 packet of Cyltezo, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. 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 Boehringer Ingelheim Pharmaceuticals, Inc. on July 01, 2023. The current certification is valid through December 31, 2027.

How is this Boehringer Ingelheim Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597037553. 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 (4-4-2)
0597-0375-53
11-Digit CMS (5-4-2)
00597-0375-53

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