NDC 50090-3491

Tresiba

Insulin Degludec

Tresiba is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Insulin Degludec.

• Product ID: 50090-3491_0f058696-8719-40e6-975a-2ea65120392c
• NDC: 50090-3491
• Product Type: Human Prescription Drug
• Proprietary Name: Tresiba
• Generic Name: Insulin Degludec
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-09-25
• Marketing Category: BLA / NDA
• Application Number: BLA203314
• Labeler Name: A-S Medication Solutions
• Substance Name: INSULIN DEGLUDEC
• Active Ingredient Strength: 200 U/mL
• Pharm Classes: Insulin [CS],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50090-3491-0

3 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0) > 3 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2018-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-3491-0 [50090349100]

Tresiba INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA203314
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-20

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN DEGLUDEC	200 U/mL

OpenFDA Data

• SPL SET ID: 84197351-cb71-4282-8217-13103404a2b4
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 54Q18076QB
• RxNorm Concept Unique ID - RxCUI:
  • 1670021
  • 1670023

Pharmacological Class

• Insulin [CS]
• Insulin Analog [EPC]

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

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
73070-400	Insulin Degludec	insulin degludec
73070-403	Insulin Degludec	insulin degludec
73070-503	Insulin Degludec	insulin degludec