NDC 70518-2143

Ozempic

Semaglutide

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

Product ID70518-2143_8b9ed314-8801-961d-e053-2a95a90a3962
NDC70518-2143
Product TypeHuman Prescription Drug
Proprietary NameOzempic
Generic NameSemaglutide
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-06-11
Marketing CategoryNDA / NDA
Application NumberNDA209637
Labeler NameREMEDYREPACK INC.
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 Through2020-12-31

Packaging

NDC 70518-2143-0

2 SYRINGE, PLASTIC in 1 CARTON (70518-2143-0) > 1.5 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2019-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2143-0 [70518214300]

Ozempic INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209637
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-11

Drug Details

Active Ingredients

IngredientStrength
SEMAGLUTIDE1.34 mg/mL

OpenFDA Data

SPL SET ID:b5399d16-01c1-4315-af3c-7619fee86621
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1991311
  • 1991306
  • Pharmacological Class

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