Lanreotide Acetate Injection
NDC 69097-880
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Lanreotide Acetate is a NDA-approved product labeled by Cipla Usa Inc.. This medication is a long-acting form of lanreotide. It is supplied as a injection for subcutaneous administration. This product entry covers the primary NDC 69097-880 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
69097-880
Proprietary Name:
Lanreotide Acetate
Non-Proprietary Name: [1]
Lanreotide Acetate
Substance Name: [2]
Lanreotide Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection
- A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
69097
Product Label ID:
FDA Application Number: [6]
NDA215395
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
12-24-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 69097-880?
The NDC code 69097-880 is assigned by the FDA to the product Lanreotide Acetate. This pharmaceutical product is labeled by Cipla Usa Inc. and is currently categorized as listed product. The medication is a injection administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 69097-880-67. 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?
This medication is a long-acting form of lanreotide. Lanreotide is used to treat a condition called acromegaly that occurs when the body makes too much of a certain natural substance called growth hormone. It is used when surgery or radiation treatment have not been fully successful or cannot be used. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Lanreotide works by decreasing the amount of growth hormone to normal levels. This drug is not a cure for acromegaly. It is used for the long-term treatment of this condition. This medication is also used to treat certain cancer or tumors of the stomach, intestines, or pancreas. It may help to slow down the growth of these tumors. Lanreotide is also used to treat carcinoid syndrome. It may help reduce the need to use another medication to treat diarrhea or flushing caused by carcinoid syndrome.
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- LANREOTIDE ACETATE (UNII: IEU56G3J9C)
- LANREOTIDE (UNII: 0G3DE8943Y) (Active Moiety)
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: 749811 - lanreotide 60 MG in 0.2 ML Prefilled Syringe
- RxCUI: 749811 - 0.2 ML lanreotide 300 MG/ML Prefilled Syringe
- RxCUI: 749811 - lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled Syringe
- RxCUI: 749814 - lanreotide 120 MG in 0.5 ML Prefilled Syringe
- RxCUI: 749814 - 0.5 ML lanreotide 240 MG/ML 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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Patient Education
Lanreotide Injection
Lanreotide injection is used to treat people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who have not successfully, or cannot be treated with surgery or radiation. Lanreotide injection is also used to treat people with neuroendocrine tumors in the gastrointestinal (GI) tract or the pancreas (GEP-NETs) that have spread or cannot be removed by surgery. Lanreotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of certain natural substances produced by the body.
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* Please review the full disclaimer at the bottom of this page.
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".
