Hadlima Solution
NDC Package 78206-183-01

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

Package Information

Hadlima (adalimumab-bwwd) solution 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 solution delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-183 and is authorized under FDA application BLA761059.

Identification & Billing

NDC Package Code
78206-183-01
Package Description
2 CARTON in 1 CARTON / 1 SYRINGE in 1 CARTON (78206-183-99) / .8 mL in 1 SYRINGE
Product Code
78206-183
11-Digit Billing Format
78206018301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hadlima
Non-Proprietary Name
Adalimumab-bwwd
Substance Name
Adalimumab
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ADALIMUMAB 40 mg/.8mL
Pharmacologic Class
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
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761059
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 78206-183-01 identifies a specific commercial package of 2 carton in 1 carton / 1 syringe in 1 carton (78206-183-99) / .8 ml in 1 syringe of Hadlima, a human prescription drug labeled by Organon Llc. This solution is formulated for subcutaneous use and contains adalimumab 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 Organon Llc on July 01, 2023. 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 Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206018301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
78206-183-01
11-Digit CMS (5-4-2)
78206-0183-01

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