NDC 0074-0067 Humira

Adalimumab Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0074-0067
Proprietary Name:
Humira
Non-Proprietary Name: [1]
Adalimumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Labeler Code:
0074
FDA Application Number: [6]
BLA125057
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
10-17-2016
End Marketing Date: [10]
07-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 0074-0067?

The NDC code 0074-0067 is assigned by the FDA to the product Humira which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Humira is adalimumab. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0074-0067-02 2 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / .4 ml in 1 syringe * 1 ml in 1 package * 1 syringe in 1 tray / .8 ml in 1 syringe. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Humira?

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).

Which are Humira UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Humira Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Humira?

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:

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Patient Education

Adalimumab Injection


Adalimumab injection products are 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) in children 2 years of age and older, 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 6 years of age and older, 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 5 years of age and older, 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 children 12 years of age and older, uveitis (swelling and inflammation of different areas of the eye) in adults and children 2 years of age and older, chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults. Adalimumab injection products are 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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Product Footnotes

[1] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".