NDC 62935-303 Eligard

Leuprolide Acetate Kit Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
62935-303
Proprietary Name:
Eligard
Non-Proprietary Name: [1]
Leuprolide Acetate
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]
    Tolmar Inc.
    Labeler Code:
    62935
    FDA Application Number: [6]
    NDA021488
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-26-2003
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 62935-303-30

    Package Description: 1 KIT in 1 CARTON * .5 mL in 1 SYRINGE (62935-305-29) * .5 mL in 1 SYRINGE (62935-304-30)

    Product Details

    What is NDC 62935-303?

    The NDC code 62935-303 is assigned by the FDA to the product Eligard which is a human prescription drug product labeled by Tolmar Inc.. The generic name of Eligard is leuprolide acetate. 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 62935-303-30 1 kit in 1 carton * .5 ml in 1 syringe (62935-305-29) * .5 ml in 1 syringe (62935-304-30). 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 Eligard?

    Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.

    Which are Eligard UNII Codes?

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

    Which are Eligard 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:

    • METHYL PYRROLIDONE (UNII: JR9CE63FPM)
    • POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 46000 MW) (UNII: LQ35R50VR1)
    • POLY(DL-LACTIC-CO-GLYCOLIC ACID), (75:25; 20000 MW) (UNII: 58X445TH30)

    What is the NDC to RxNorm Crosswalk for Eligard?

    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: 752884 - leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled Syringe
    • RxCUI: 752884 - 0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe
    • RxCUI: 752884 - leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled Syringe
    • RxCUI: 752884 - leuprolide acetate 45 MG per 0.375 ML Prefilled Syringe
    • RxCUI: 752889 - leuprolide acetate 30 MG in 0.5 ML (4 month) Prefilled Syringe

    * Please review the disclaimer below.

    Patient Education

    Leuprolide Injection


    Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer. Leuprolide injection (Lupron Depot-PED, Fensolvi) is used in children 2 years of age or older to treat central precocious puberty (CPP; a condition causing girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics). Leuprolide injection (Lupron Depot) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Leuprolide injection (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus). Leuprolide injection is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the 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.

    [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".