Lanreotide Acetate Injection
NDC Package 70121-2517-5

11-digit billing NDC: 70121251705

Package Information

Lanreotide Acetate injection is a medication a long-acting form of lanreotide. This formulation utilizes a injection delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 70121-2517 and is authorized under FDA application ANDA218217.

Identification & Billing

NDC Package Code
70121-2517-5
Package Description
1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .5 mL in 1 SYRINGE, PLASTIC
Product Code
11-Digit Billing Format
70121251705

Clinical Specifications

Proprietary Name
Lanreotide Acetate
Non-Proprietary Name
Lanreotide Acetate
Substance Name
Lanreotide Acetate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218217
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2026
Listing Expiration
12-31-2027
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 70121-2517-5 identifies a specific commercial package of 1 pouch in 1 carton / 1 syringe, plastic in 1 pouch / .5 ml in 1 syringe, plastic of Lanreotide Acetate, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This injection is formulated for subcutaneous use and contains lanreotide 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 Amneal Pharmaceuticals Llc on September 23, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70121251705. 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 (5-4-1)
70121-2517-5
11-Digit CMS (5-4-2)
70121-2517-05

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