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 ID50090-3491_0f058696-8719-40e6-975a-2ea65120392c
NDC50090-3491
Product TypeHuman Prescription Drug
Proprietary NameTresiba
Generic NameInsulin Degludec
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-09-25
Marketing CategoryBLA / NDA
Application NumberBLA203314
Labeler NameA-S Medication Solutions
Substance NameINSULIN DEGLUDEC
Active Ingredient Strength200 U/mL
Pharm ClassesInsulin [CS],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50090-3491-0

3 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0) > 3 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2018-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-3491-0 [50090349100]

Tresiba INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA203314
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-20

Drug Details

Active Ingredients

IngredientStrength
INSULIN DEGLUDEC200 U/mL

OpenFDA Data

SPL SET ID:84197351-cb71-4282-8217-13103404a2b4
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0169-2550Tresibainsulin degludec injection
    0169-2660Tresibainsulin degludec injection
    0169-2662Tresibainsulin degludec injection
    50090-3491Tresibainsulin degludec
    73070-400Insulin Degludecinsulin degludec
    73070-403Insulin Degludecinsulin degludec
    73070-503Insulin Degludecinsulin degludec

    Trademark Results [Tresiba]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRESIBA
    TRESIBA
    79080004 3841743 Live/Registered
    Novo Nordisk A/S
    2010-02-03

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.