Humira Kit
NDC Package 83457-554-02

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

Package Information

Humira (adalimumab) kits is adalimumab is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, ankylosing spondylitis). This formulation utilizes a kit delivery system. Marketed by Cordavis Limited, this product is identified by NDC 83457-554 and is authorized under FDA application BLA125057.

Identification & Billing

NDC Package Code
83457-554-02
Package Description
2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-553-01) / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01)
Product Code
83457-554
11-Digit Billing Format
83457055402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Humira
Non-Proprietary Name
Adalimumab
Dosage Form
Kit - A packaged collection of related material.
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).

Regulatory & Marketing

Labeler Name
Cordavis Limited
Product Type
Human Prescription Drug
FDA Application #
BLA125057
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-14-2024
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0135
Source: PDAC
INJECTION, ADALIMUMAB, 20 MG
HCPCS Dosage 20 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 83457-554-02 identifies a specific commercial package of 2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray (83457-553-01) / .4 ml in 1 syringe * 1 ml in 1 packet (83457-927-01) of Humira, a human prescription drug labeled by Cordavis Limited. 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 Cordavis Limited on February 14, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Cordavis Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83457055402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
83457-554-02
11-Digit CMS (5-4-2)
83457-0554-02

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