NDC 0169-4136

Ozempic

Semaglutide

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

Product ID0169-4136_16fb5f2c-ad9e-4a1e-9a82-6c888cd7fe13
NDC0169-4136
Product TypeHuman Prescription Drug
Proprietary NameOzempic
Generic NameSemaglutide
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-12-06
Marketing CategoryNDA / NDA
Application NumberNDA209637
Labeler NameNovo Nordisk
Substance NameSEMAGLUTIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesGLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0169-4136-02

2 SYRINGE, PLASTIC in 1 CARTON (0169-4136-02) > 1.5 mL in 1 SYRINGE, PLASTIC (0169-4136-11)
Marketing Start Date2017-12-06
Marketing End Date2023-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-4136-02 [00169413602]

Ozempic INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209637
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-06

NDC 0169-4136-11 [00169413611]

Ozempic INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209637
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-06

Drug Details

Active Ingredients

IngredientStrength
SEMAGLUTIDE1.34 mg/mL

OpenFDA Data

SPL SET ID:adec4fd2-6858-4c99-91d4-531f5f2a2d79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1991311
  • 1991317
  • 1991316
  • 1991306
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Ozempic" or generic name "Semaglutide"

    NDCBrand NameGeneric Name
    0169-4130Ozempicsemaglutide
    0169-4132Ozempicsemaglutide
    0169-4136Ozempicsemaglutide
    0169-4181Ozempicsemaglutide
    0169-4772Ozempicsemaglutide
    50090-5138Ozempicsemaglutide
    50090-5139Ozempicsemaglutide
    70518-2143OzempicOzempic
    0169-4501WEGOVYsemaglutide
    0169-4505WEGOVYsemaglutide
    0169-4517WEGOVYsemaglutide
    0169-4524WEGOVYsemaglutide
    0169-4525WEGOVYsemaglutide

    Trademark Results [Ozempic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OZEMPIC
    OZEMPIC
    79159431 4774881 Live/Registered
    Novo Nordisk A/S
    2014-12-03

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