Xultophy 100/3.6 Injection, Solution
NDC Package 0169-2911-97

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

Package Information

Xultophy 100/3.6 (insulin degludec and liraglutide) injection is xULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).Limitations of Use:•XULTOPHY 100/3.6 is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans [see Warnings and Precautions (5.1)].•XULTOPHY 100/3.6 has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. This formulation utilizes a injection, solution delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-2911 and is authorized under FDA application BLA208583.

Identification & Billing

NDC Package Code
0169-2911-97
Package Description
1 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC (0169-2911-90)
Product Code
0169-2911
11-Digit Billing Format
00169291197
RxNorm Crosswalk
  • RxCUI: 1860167 - insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML in 3 ML Pen Injector
  • RxCUI: 1860167 - 3 ML insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML Pen Injector
  • RxCUI: 1860167 - insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML per 3 ML Pen Injector
  • RxCUI: 1860172 - Xultophy 100/3.6 in 3 ML Pen Injector
  • RxCUI: 1860172 - 3 ML insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML Pen Injector [Xultophy]

Clinical Specifications

Proprietary Name
Xultophy 100/3.6
Non-Proprietary Name
Insulin Degludec And Liraglutide
Substance Name
Insulin Degludec; 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)
Pharmacologic Class
Usage Information
XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).Limitations of Use:•XULTOPHY 100/3.6 is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans [see Warnings and Precautions (5.1)].•XULTOPHY 100/3.6 has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. Consider other antidiabetic therapies in patients with a history of pancreatitis.•XULTOPHY 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist [see Warnings and Precautions (5.5)].•XULTOPHY 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.•XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Human Prescription Drug
FDA Application #
BLA208583
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-21-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0169-2911). Click a package code to view its specific billing and regulatory data.

0169-2911-15
5 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 0169-2911-97 identifies a specific commercial package of 1 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic (0169-2911-90) of Xultophy 100/3.6, a human prescription drug labeled by Novo Nordisk. This injection, solution is formulated for subcutaneous use and contains insulin degludec; 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 Novo Nordisk on November 21, 2016. The current certification is valid through December 31, 2026.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169291197. 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 (4-4-2)
0169-2911-97
11-Digit CMS (5-4-2)
00169-2911-97

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