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  4. NDC Product Code: 44087-8822 Rebif

NDC 44087-8822 Rebif

Interferon Beta-1a Kit Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 44087-8822?
  4. Rebif Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
44087-8822
Proprietary Name:
Rebif
Non-Proprietary Name: [1]
Interferon Beta-1a
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.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Emd Serono, Inc.
    Labeler Code:
    44087
    Product Label ID:
    c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f
    FDA Application Number: [6]
    BLA103780
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    12-17-2004
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 44087-8822-1

    Package Description: 1 KIT in 1 CARTON * .2 mL in 1 SYRINGE, GLASS * .5 mL in 1 SYRINGE, GLASS

    Product Details

    What is NDC 44087-8822?

    The NDC code 44087-8822 is assigned by the FDA to the product Rebif which is a human prescription drug product labeled by Emd Serono, Inc.. The generic name of Rebif is interferon beta-1a. The product's dosage form is kit and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 44087-8822-1 1 kit in 1 carton * .2 ml in 1 syringe, glass * .5 ml in 1 syringe, glass. 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 Rebif?

    This medication is used to treat multiple sclerosis (MS). Interferon is not a cure for MS, but it may help to slow disease worsening and decrease flare-ups of symptoms (such as balance problems, numbness, or weakness).

    Which are Rebif UNII Codes?

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

    Which are Rebif 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 Rebif?

    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:

    * Please review the disclaimer below.

    Patient Education

    Interferon Beta-1a Intramuscular Injection


    Interferon beta-1a intramuscular injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Interferon beta-1a is in a class of medications called immunomodulators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.
    [Learn More]


    Interferon Beta-1a Subcutaneous Injection


    Interferon beta-1a subcutaneous injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Interferon beta-1a is in a class of medications called immunomodulators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.
    [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.

    [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".