NDC 61703-343 Mitoxantrone

Injection, Solution, Concentrate Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
61703-343
Proprietary Name:
Mitoxantrone
Non-Proprietary Name: [1]
Mitoxantrone
Substance Name: [2]
Mitoxantrone Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Hospira, Inc.
    Labeler Code:
    61703
    FDA Application Number: [6]
    ANDA076871
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    04-11-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 61703-343-18

    Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

    NDC Code 61703-343-65

    Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON / 12.5 mL in 1 VIAL, MULTI-DOSE

    NDC Code 61703-343-66

    Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON / 15 mL in 1 VIAL, MULTI-DOSE

    Product Details

    What is NDC 61703-343?

    The NDC code 61703-343 is assigned by the FDA to the product Mitoxantrone which is a human prescription drug product labeled by Hospira, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form. The product is distributed in 3 packages with assigned NDC codes 61703-343-18 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose, 61703-343-65 1 vial, multi-dose in 1 carton / 12.5 ml in 1 vial, multi-dose, 61703-343-66 1 vial, multi-dose in 1 carton / 15 ml in 1 vial, multi-dose. 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 Mitoxantrone?

    Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis.The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.Mitoxantrone in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.Mitoxantrone in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.

    What are Mitoxantrone 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 Mitoxantrone UNII Codes?

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

    Which are Mitoxantrone 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 Mitoxantrone?

    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: 197989 - mitoXANTRONE 2 MG/ML Injectable Solution
    • RxCUI: 197989 - mitoxantrone 2 MG/ML Injectable Solution
    • RxCUI: 197989 - mitoxantrone (as mitoxantrone hydrochloride) 2 MG/ML Injectable Solution
    • RxCUI: 197989 - mitoxantrone 20 MG per 10 ML Injectable Solution
    • RxCUI: 197989 - mitoxantrone 25 MG per 12.5 ML Injectable Solution

    Which are the Pharmacologic Classes for Mitoxantrone?

    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

    Mitoxantrone Injection


    Mitoxantrone injection is used to 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 the following: relapsing-remitting forms (course of disease where symptoms flare up from time to time), or progressive relapsing (course of disease with occasional relapses), or secondary progressive forms (course of disease where relapses occur more often). Mitoxantrone injection is also used together with steroid medications to relieve pain in people with advanced prostate cancer who did not respond to other medications. Mitoxantrone injection is also used with other medications to treat certain types of leukemia. Mitoxantrone injection is in a class of medications called anthracenediones. Mitoxantrone treats MS by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage. Mitoxantrone treats cancer by stopping the growth and spread of cancer cells.
    [Learn More]


    Cancer Chemotherapy


    What is cancer chemotherapy?

    Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

    Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

    Chemotherapy is used to:

    • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
    • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

    What are the side effects of chemotherapy?

    Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

    You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

    Some common side effects are:

    There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

    What can I expect when getting chemotherapy?

    You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

    Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

    Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

    NIH: National Cancer Institute


    [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".