Sandostatin Lar Depot Kit
NDC 0078-0818

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0078-0818?
  4. Sandostatin Lar Depot Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Sandostatin Lar Depot (octreotide acetate) is a NDA-approved product labeled by Novartis Pharmaceuticals Corporation. This medication is a long-acting form of octreotide. It is supplied as a kit. This product entry covers the primary NDC 0078-0818 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0078-0818
Proprietary Name:
Sandostatin Lar Depot
Non-Proprietary Name: [1]
Octreotide Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Novartis Pharmaceuticals Corporation
Labeler Code:
0078
Product Label ID:
d0b7fe9e-7000-4b79-ba3b-291ce92c14f9
HCPCS Code:
J2353 - INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG
FDA Application Number: [6]
NDA021008
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-22-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0078-0818?

The NDC code 0078-0818 is assigned by the FDA to the product Sandostatin Lar Depot. It is commonly known by its generic name, octreotide acetate. This pharmaceutical product is labeled by Novartis Pharmaceuticals Corporation and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0078-0818-81. 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 octreotide. Octreotide is used to treat severe watery diarrhea and sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas. The symptoms occur when these tumors make too much of certain natural substances (hormones). This medication works by blocking the production of these hormones. By decreasing watery diarrhea, octreotide helps to reduce the loss of body fluids and minerals. Octreotide is also used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Octreotide works by decreasing the amount of growth hormone to normal levels. This drug is not a cure for these conditions. This medication is usually used with other treatment (such as surgery, radiation, other drugs).

Which are the associated UNII Codes?

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

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:

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:

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Patient Education

Octreotide Injection


Octreotide immediate-release injection is used to decrease the amount of growth hormone (a natural substance) produced by 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 cannot be treated with surgery, radiation, or another medication. Octreotide immediate-release injection is also used to control diarrhea and flushing caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms) and vasoactive intestinal peptide secreting adenomas (VIP-omas; tumors that form in the pancreas and release natural substances that can cause symptoms). Octreotide long-acting injection is used to control acromegaly, carcinoid tumors, and VIP-omas in people who have been successfully treated with octreotide injection but prefer to receive injections less often. Octreotide injection is in a class of medications called octapeptides. 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 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 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".