NDC 0169-3687

Levemir

Insulin Detemir

Levemir is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Detemir.

Product ID0169-3687_18faddbd-0bc0-48d1-a16f-f4939de3d0a3
NDC0169-3687
Product TypeHuman Prescription Drug
Proprietary NameLevemir
Generic NameInsulin Detemir
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2006-03-27
Marketing CategoryBLA / NDA
Application NumberBLA021536
Labeler NameNovo Nordisk
Substance NameINSULIN DETEMIR
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0169-3687-12

1 VIAL, GLASS in 1 CARTON (0169-3687-12) > 10 mL in 1 VIAL, GLASS
Marketing Start Date2006-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-3687-12 [00169368712]

Levemir INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021536
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-03-27

Drug Details

Active Ingredients

IngredientStrength
INSULIN DETEMIR100 [iU]/mL

OpenFDA Data

SPL SET ID:d38d65c1-25bf-401d-9c7e-a2c3222da8af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 847241
  • 847239
  • 616238
  • 484322
  • PHarm Class EPC
  • Insulin Analog [EPC]
  • NUI Code
  • N0000175453
  • N0000004931
  • Pharmacological Class

    • Insulin [Chemical/Ingredient]
    • Insulin Analog [EPC]

    NDC Crossover Matching brand name "Levemir" or generic name "Insulin Detemir"

    NDCBrand NameGeneric Name
    0169-3687Levemirinsulin detemir
    0169-6432Levemirinsulin detemir
    0169-6438Levemirinsulin detemir
    50090-1276Levemirinsulin detemir
    50090-1475Levemirinsulin detemir
    50090-4501Levemirinsulin detemir
    68258-8977Levemirinsulin detemir
    70518-1387Levemirinsulin detemir
    70518-1462Levemirinsulin detemir

    Trademark Results [Levemir]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LEVEMIR
    LEVEMIR
    76468735 2808088 Live/Registered
    Novo Nordisk A/S
    2002-11-07

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