Adalimumab Injection
NDC Package 43835-0035-2

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Adalimumab injection 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 injection delivery system. Marketed by Novo Nordisk Production Belgium Sa, this product is identified by NDC 43835-0035.

Identification & Billing

NDC Package Code
43835-0035-2
Package Description
170 SYRINGE in 1 BOX / .4 mL in 1 SYRINGE
Product Code
43835-0035
11-Digit Billing Format
43835003502

Clinical Specifications

Proprietary Name
Adalimumab
Non-Proprietary Name
Adalimumab
Substance Name
Adalimumab-bwwd
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
ADALIMUMAB-BWWD 100 mg/mL
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
Novo Nordisk Production Belgium Sa
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (43835-0035). Click a package code to view its specific billing and regulatory data.

43835-0035-1
224 SYRINGE in 1 BOX / .4 mL in 1 SYRINGE

* 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 43835-0035-2 identifies a specific commercial package of 170 syringe in 1 box / .4 ml in 1 syringe of Adalimumab (UNFINISHED drug), drug for further processing labeled by Novo Nordisk Production Belgium Sa. This injection is formulated for use and contains adalimumab-bwwd 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 Novo Nordisk Production Belgium Sa on July 01, 2023. The current certification is valid through December 31, 2026.

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 Novo Nordisk Production Belgium Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43835003502. 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 (5-4-1)
43835-0035-2
11-Digit CMS (5-4-2)
43835-0035-02

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