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  5. NDC Package Code: 0169-2911-15 Xultophy 100/3.6

NDC Package 0169-2911-15 Xultophy 100/3.6

(insulin Degludec And Liraglutide) Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0169-2911-15
Package Description:
5 SYRINGE, PLASTIC in 1 CARTON / 3 mL in 1 SYRINGE, PLASTIC
Product Code:
0169-2911
Proprietary Name:
Xultophy 100/3.6
Non-Proprietary Name:
(insulin Degludec And Liraglutide)
Substance Name:
Insulin Degludec; Liraglutide
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.
11-Digit NDC Billing Format:
00169291115
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novo Nordisk
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • INSULIN DEGLUDEC 100 [iU]/mL
  • LIRAGLUTIDE 3.6 mg/mL
    • Pharmacologic Class(es):
  • GLP-1 Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Glucagon-Like Peptide 1 - [CS]
  • Glucagon-like Peptide-1 (GLP-1) Agonists - [MoA] (Mechanism of Action)
  • Insulin Analog - [EPC] (Established Pharmacologic Class)
  • Insulin - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA208583
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-21-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0169-2911-15?

    The NDC Packaged Code 0169-2911-15 is assigned to a package of 5 syringe, plastic in 1 carton / 3 ml in 1 syringe, plastic of Xultophy 100/3.6, a human prescription drug labeled by Novo Nordisk. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 0169-2911 included in the NDC Directory?

    Yes, Xultophy 100/3.6 with product code 0169-2911 is active and included in the NDC Directory. The product was first marketed by Novo Nordisk on November 21, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0169-2911-15?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0169-2911-15?

    The 11-digit format is 00169291115. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20169-2911-155-4-200169-2911-15