NDC 0169-2911

Xultophy 100/3.6

(insulin Degludec And Liraglutide)

Xultophy 100/3.6 is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Degludec; Liraglutide.

Product ID0169-2911_50d14aa3-54d6-4af2-9d25-99529af63053
NDC0169-2911
Product TypeHuman Prescription Drug
Proprietary NameXultophy 100/3.6
Generic Name(insulin Degludec And Liraglutide)
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-11-21
Marketing CategoryNDA / NDA
Application NumberNDA208583
Labeler NameNovo Nordisk
Substance NameINSULIN DEGLUDEC; LIRAGLUTIDE
Active Ingredient Strength100 [iU]/mL; mg/mL
Pharm ClassesInsulin [CS],Insulin Analog [EPC],GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0169-2911-15

5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) > 3 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2016-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-2911-90 [00169291190]

Xultophy 100/3.6 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208583
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-21

NDC 0169-2911-15 [00169291115]

Xultophy 100/3.6 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-11-21

NDC 0169-2911-97 [00169291197]

Xultophy 100/3.6 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208583
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-21

Drug Details

Active Ingredients

IngredientStrength
INSULIN DEGLUDEC100 [iU]/mL

OpenFDA Data

SPL SET ID:21335fe4-d395-4501-ac2a-2f20d7520da9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860172
  • 1860167
  • Pharmacological Class

    • Insulin [CS]
    • Insulin Analog [EPC]
    • GLP-1 Receptor Agonist [EPC]
    • Glucagon-Like Peptide 1 [CS]
    • Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

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