Lanreotide Acetate
NDC 76282-709
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Lanreotide Acetate is a NDA-approved product labeled by Exelan Pharmaceuticals, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 76282-709 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
76282-709
Proprietary Name:
Lanreotide Acetate
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
76282
FDA Application Number: [6]
NDA215395
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
06-01-2022
End Marketing Date: [10]
08-18-2023
Listing Expiration Date: [11]
08-18-2023
Exclude Flag: [12]
D
Code Structure Chart
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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Product & Regulatory Definitions
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
