Hyrimoz Injection, Solution
NDC Package 83457-101-01
Package Information
Hyrimoz (adalimumab-adaz) 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, solution delivery system. Marketed by Cordavis Limited, this product is identified by NDC 83457-101 and is authorized under FDA application BLA761071.
Identification & Billing
- RxCUI: 2641653 - adalimumab-adaz 20 MG in 0.2 ML Prefilled Syringe
- RxCUI: 2641653 - 0.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe
- RxCUI: 2641653 - adalimumab-adaz 20 MG per 0.2 ML Prefilled Syringe
- RxCUI: 2641654 - Hyrimoz 20 MG in 0.2 ML Prefilled Syringe
- RxCUI: 2641654 - 0.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 83457 - Cordavis Limited
- 83457-101 - Hyrimoz
- 83457-101-01 - 2 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS
- 83457-101 - Hyrimoz
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 83457-101-01 identifies a specific commercial package of 2 syringe, glass in 1 carton / .4 ml in 1 syringe, glass of Hyrimoz, a human prescription drug labeled by Cordavis Limited. This injection, 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 Cordavis Limited on September 21, 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 Cordavis Limited product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 83457010101. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.