Eligard Injection, Suspension, Extended Release
NDC 62935-306
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Eligard (leuprolide acetate) is a NDA-approved product labeled by Tolmar Inc.. Leuprolide is used to treat advanced prostate cancer in men. It is supplied as a injection, suspension, extended release for subcutaneous administration. This product entry covers the primary NDC 62935-306 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
62935-306
Proprietary Name:
Eligard
Non-Proprietary Name: [1]
Leuprolide Acetate
Substance Name: [2]
Leuprolide Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Suspension, Extended Release
- A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
62935
Product Label ID:
HCPCS Code:
J9217
- Leuprolide acetate suspnsion
FDA Application Number: [6]
NDA021488
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-11-2024
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 62935-306?
The NDC code 62935-306 is assigned by the FDA to the product Eligard. It is commonly known by its generic name, leuprolide acetate. This pharmaceutical product is labeled by Tolmar Inc. and is currently categorized as listed product. The medication is a injection, suspension, extended release administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 62935-306-40. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What are Active Ingredients of this product?
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.
- LEUPROLIDE ACETATE 30 mg/.5mL - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- LEUPROLIDE ACETATE (UNII: 37JNS02E7V)
- LEUPROLIDE (UNII: EFY6W0M8TG) (Active Moiety)
Which are the Inactive Ingredients associated 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 this product?
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
Which are the Pharmacologic Classes of this product?
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.
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
