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  2. E.r. Squibb & Sons, L.l.c.
  3. NDC Product Code: 0003-2187 Orencia

NDC 0003-2187 Orencia

Abatacept Injection, Powder, Lyophilized, For Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0003-2187?
    4. Orencia Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. Pharmacologic Classes
    9. Patient Education

Product Information

NDC Product Code:
0003-2187
Proprietary Name:
Orencia
Non-Proprietary Name: [1]
Abatacept
Substance Name: [2]
Abatacept
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    E.r. Squibb & Sons, L.l.c.
    Labeler Code:
    0003
    Product Label ID:
    0836c6ac-ee37-5640-2fed-a3185a0b16eb
    FDA Application Number: [6]
    BLA125118
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-01-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0003-2187-10

    Package Description: 1 VIAL, SINGLE-USE in 1 CELLO PACK / 15 mL in 1 VIAL, SINGLE-USE

    Price per Unit: $677.28937 per EA

    NDC Code 0003-2187-13

    Package Description: 1 VIAL, SINGLE-USE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-USE

    Product Details

    What is NDC 0003-2187?

    The NDC code 0003-2187 is assigned by the FDA to the product Orencia which is a human prescription drug product labeled by E.r. Squibb & Sons, L.l.c.. The generic name of Orencia is abatacept. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 0003-2187-10 1 vial, single-use in 1 cello pack / 15 ml in 1 vial, single-use, 0003-2187-13 1 vial, single-use in 1 carton / 15 ml in 1 vial, single-use. 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 Orencia?

    This medication is used to treat rheumatoid arthritis, a condition in which the body's own defense system (immune system) attacks healthy tissue. This leads to swelling in the joints, which causes pain and makes it harder to move. Abatacept works by weakening your immune system. This effect helps to slow down joint damage and reduce joint pain and swelling so you can move better. This medication is also used to treat other types of arthritis (such as juvenile idiopathic arthritis, psoriatic arthritis).

    What are Orencia 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.
    • ABATACEPT 250 mg/15mL - A fusion protein immunoconjugate of the extracellular domain of CTLA4 and the Fc domain of human IgG1. It functions as a T-cell co-stimulation blocker that inhibits TNF-ALPHA and prevents the activation of T-LYMPHOCYTES. It is used in the treatment of RHEUMATOID ARTHRITIS.

    Which are Orencia UNII Codes?

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

    Which are Orencia 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:

    Which are the Pharmacologic Classes for Orencia?

    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

    Abatacept Injection


    Abatacept is used: alone or in combination with other medications to reduce the pain, swelling, difficulty with daily activities, and joint damage caused by rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who have not been helped by other medications. alone or in combination with methotrexate (Otrexup, Rasuvo, Reditrex, Trexall, Xatmep) to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age or older. alone or in combination with other medications to treat psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults. in combination with a calcineurin inhibitor (e.g., cyclosporine [Gengraf, Neoral, Sandimmune], tacrolimus [Astagraf, Prograf]) and methotrexate to prevent graft-versus-host disease (GVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow]) in adults and children 2 years of age and older. Abatacept is in a class of medications called selective costimulation modulators (immunomodulators). It works by blocking the activity of T-cells, a type of immune cell in the body that causes swelling and joint damage in people who have arthritis.
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    * 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".