NDC 16714-908 Bleomycin

Powder, For Solution Intramuscular; Intrapleural; Intravenous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
16714-908
Proprietary Name:
Bleomycin
Non-Proprietary Name: [1]
Bleomycin
Substance Name: [2]
Bleomycin Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intrapleural - Administration within the pleura.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Northstar Rx Llc
    Labeler Code:
    16714
    FDA Application Number: [6]
    ANDA205030
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    12-01-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 16714-908-01

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 16714-908?

    The NDC code 16714-908 is assigned by the FDA to the product Bleomycin which is a human prescription drug product labeled by Northstar Rx Llc. The product's dosage form is powder, for solution and is administered via intramuscular; intrapleural; intravenous; subcutaneous form. The product is distributed in a single package with assigned NDC code 16714-908-01 1 vial, single-dose in 1 carton / 30 powder, for solution in 1 vial, single-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 Bleomycin?

    Bleomycin is used to treat cancer. It works by slowing or stopping the growth of cancer cells. This medication may also be used to control the build-up of fluid around the lungs (pleural effusion) caused by tumors that have spread to the lungs. For this condition, bleomycin is placed in the space around the lungs through a chest tube.

    What are Bleomycin 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.
    • BLEOMYCIN SULFATE 30 [USP'U]/1 - A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.

    Which are Bleomycin UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Bleomycin?

    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 Bleomycin?

    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

    Bleomycin


    Bleomycin injection is used alone or in combination with other medications to treat head and neck cancer (including cancer of the mouth, lip, cheek, tongue, palate, throat, tonsils, and sinuses) and cancer of the penis, testicles, cervix, and vulva (the outer part of the vagina). Bleomycin is also used to treat Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system) in combination with other medications. It is also used to treat pleural effusions (a condition when fluid collects in the lungs) that are caused by cancerous tumors. Bleomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.
    [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".