Octreotide Acetate Injection, Solution
NDC Package 68083-516-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Octreotide Acetate injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-516 and is authorized under FDA application ANDA216807.

Identification & Billing

NDC Package Code
68083-516-01
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
68083-516
11-Digit Billing Format
68083051601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Octreotide Acetate
Non-Proprietary Name
Octreotide Acetate
Substance Name
Octreotide Acetate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
OCTREOTIDE ACETATE 1000 ug/mL
Pharmacologic Class
Usage Information
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).

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216807
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-13-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68083-516-01 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Octreotide Acetate, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intravenous; subcutaneous use and contains octreotide acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Gland Pharma Limited on June 13, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083051601. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68083-516-01
11-Digit CMS (5-4-2)
68083-0516-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.