Adalimumab-ryvk Kit
NDC 82009-158
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Adalimumab-ryvk is a BLA-approved product labeled by Quallent Pharmaceuticals Health Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit for subcutaneous administration. This product entry covers the primary NDC 82009-158 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
82009-158
Proprietary Name:
Adalimumab-ryvk
Non-Proprietary Name: [1]
Adalimumab-ryvk
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
82009
Product Label ID:
FDA Application Number: [6]
BLA761299
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
07-31-2024
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 82009-158?
The NDC code 82009-158 is assigned by the FDA to the product Adalimumab-ryvk. This pharmaceutical product is labeled by Quallent Pharmaceuticals Health Llc and is currently categorized as listed product. The medication is a kit administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 82009-158-22. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
None.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 2677780 - adalimumab-ryvk 40 MG in 0.4 ML Auto-Injector
- RxCUI: 2677780 - 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector
- RxCUI: 2677780 - adalimumab-ryvk 40 MG per 0.4 ML Auto-Injector
- RxCUI: 2688826 - adalimumab-ryvk 40 MG in 0.4 ML Prefilled Syringe
- RxCUI: 2688826 - 0.4 ML adalimumab-ryvk 100 MG/ML Prefilled Syringe
* Please review the full disclaimer at the bottom of this page.
Patient Education
Adalimumab Injection
Adalimumab injection is used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following: rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications in adults and children ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) when other medications and treatments did not help or could not be tolerated in adults and children ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults hidradenitis suppurativa (a skin disease that causes pimple-like bumps in the armpits, groin, and anal area) in adults and teenagers uveitis (swelling and inflammation of different areas of the eye) in adults and children chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults Adalimumab injection is in a class of medications called tumor necrosis factor (TNF) inhibitors. They work by blocking the action of TNF, a substance in the body that causes inflammation.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
