NDC 0169-2662

Tresiba

Insulin Degludec Injection

Tresiba 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.

• Product ID: 0169-2662_b7aeb64e-5f1b-458e-ae42-e89ba622a60a
• NDC: 0169-2662
• Product Type: Human Prescription Drug
• Proprietary Name: Tresiba
• Generic Name: Insulin Degludec Injection
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-11-21
• Marketing Category: BLA / NDA
• Application Number: BLA203314
• Labeler Name: Novo Nordisk
• Substance Name: INSULIN DEGLUDEC
• Active Ingredient Strength: 100 U/mL
• Pharm Classes: Insulin [CS],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0169-2662-11

1 VIAL, GLASS in 1 CARTON (0169-2662-11) > 10 mL in 1 VIAL, GLASS

• Marketing Start Date: 2019-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-2662-90 [00169266290]

Tresiba INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA203314
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-05

NDC 0169-2662-11 [00169266211]

Tresiba INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA203314
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-05

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN DEGLUDEC	100 U/mL

OpenFDA Data

• SPL SET ID: 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6
• Manufacturer:
  • Novo Nordisk
• UNII:
  • 54Q18076QB
• RxNorm Concept Unique ID - RxCUI:
  • 1670023
  • 1670011
  • 2107520
  • 1670021
  • 1670016
  • 2107522

Pharmacological Class

• Insulin [CS]
• Insulin Analog [EPC]

NDC Crossover Matching brand name "Tresiba" or generic name "Insulin Degludec Injection"

NDC	Brand Name	Generic Name
0169-2550	Tresiba	insulin degludec injection
0169-2660	Tresiba	insulin degludec injection
0169-2662	Tresiba	insulin degludec injection
50090-3491	Tresiba	insulin degludec