Liraglutide Injection, Solution
NDC Package 81607-018-02

11-digit billing NDC: 81607001802
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Liraglutide injection is indicated:as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.Limitations of Use:Liraglutide injection contains liraglutide. This formulation utilizes a injection, solution delivery system. Marketed by Orbicular Pharmaceutical Technologies Private Limited, this product is identified by NDC 81607-018 and is authorized under FDA application ANDA217590.

Identification & Billing

NDC Package Code
81607-018-02
Package Description
2 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC
Product Code
81607-018
11-Digit Billing Format
81607001802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Liraglutide
Non-Proprietary Name
Liraglutide
Substance Name
Liraglutide
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
LIRAGLUTIDE 6 mg/mL
Pharmacologic Class
Usage Information
Liraglutide injection is indicated:as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.Limitations of Use:Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.

Regulatory & Marketing

Labeler Name
Orbicular Pharmaceutical Technologies Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217590
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-21-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81607-018). Click a package code to view its specific billing and regulatory data.

81607-018-01
3 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC

* 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 81607-018-02 identifies a specific commercial package of 2 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic of Liraglutide, a human prescription drug labeled by Orbicular Pharmaceutical Technologies Private Limited. This injection, solution is formulated for subcutaneous use and contains liraglutide 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 Orbicular Pharmaceutical Technologies Private Limited on January 21, 2026. The current certification is valid through December 31, 2027.

How is this Orbicular Pharmaceutical Technologies Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81607001802. 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)
81607-018-02
11-Digit CMS (5-4-2)
81607-0018-02

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