NDC 0074-2306 Rinvoq

Upadacitinib Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0074-2306
Proprietary Name:
Rinvoq
Non-Proprietary Name: [1]
Upadacitinib
Substance Name: [2]
Upadacitinib
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Abbvie Inc.
    Labeler Code:
    0074
    FDA Application Number: [6]
    NDA211675
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-16-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PURPLE (C48327)
    Shape:
    OVAL (C48345)
    Size(s):
    14 MM
    Imprint(s):
    A15
    Score:
    1

    Product Packages

    NDC Code 0074-2306-30

    Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $208.19577 per EA

    NDC Code 0074-2306-70

    Package Description: 14 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 0074-2306?

    The NDC code 0074-2306 is assigned by the FDA to the product Rinvoq which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Rinvoq is upadacitinib. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0074-2306-30 30 tablet, extended release in 1 bottle , 0074-2306-70 14 tablet, extended release in 1 bottle . 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 Rinvoq?

    Upadacitinib is used to treat rheumatoid arthritis. It helps decrease pain, tenderness, and swelling in the joints.

    What are Rinvoq Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Rinvoq UNII Codes?

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

    Which are Rinvoq 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 Rinvoq?

    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:

    Which are the Pharmacologic Classes for Rinvoq?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Upadacitinib


    Upadacitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s). It is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s). Upadacitinib is also used to treat symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years and older who cannot use other medications for their condition or whose eczema has not responded to other medications. It is also used to treat ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Upadacitinib is used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Upadacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.
    [Learn More]


    * Please review the disclaimer below.

    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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [11] 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.

    [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".