NDC 0074-3641 Lupron Depot
Leuprolide Acetate Kit

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0074-3641?
    4. Lupron Depot Uses
    5. Active Ingredients UNII Codes
    6. Inactive Ingredients UNII Codes
    7. NDC to RxNorm Crosswalk
    8. Patient Education

Product Information

NDC Product Code0074-3641
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Lupron Depot
Non-Proprietary Name 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.		Leuprolide Acetate
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Abbvie Inc.
Labeler Code0074
SPL SET ID:00c486b0-bd7b-4898-834d-8c656e5e73cb
FDA Application Number 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.		NDA020011
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		10-22-1990
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0074-3641-03

Package Description: 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET

Price per Unit: $1580.75251 per EA

NDC Code 0074-3641-71

Package Description: 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET

Product Details

What is NDC 0074-3641?

The NDC code 0074-3641 is assigned by the FDA to the product Lupron Depot which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Lupron Depot is leuprolide acetate. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 0074-3641-03 1 kit in 1 carton * 1 ml in 1 syringe * 1 ml in 1 packet, 0074-3641-71 1 kit in 1 carton * 1 ml in 1 syringe * 1 ml in 1 packet. 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 Lupron Depot?

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 Lupron Depot UNII Codes?

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

Which are Lupron Depot 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 Lupron Depot?

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: 1115457 - leuprolide acetate 3.75 MG in 1 ML (1 month) Prefilled Syringe
  • RxCUI: 1115457 - 1 ML leuprolide acetate 3.75 MG/ML Prefilled Syringe
  • RxCUI: 1115457 - leuprolide acetate 3.75 MG per 1 ML (1 month) Prefilled Syringe
  • RxCUI: 1115457 - leuprolide acetate 3.75 MG per 1 ML Prefilled Syringe
  • RxCUI: 1115459 - Lupron Depot 3.75 MG in 1 ML (1 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.
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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


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