NDC 67386-130

Vyepti

Eptinezumab-jjmr

Vyepti is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Eptinezumab.

Product ID67386-130_1156608e-bd62-4927-b627-f8a24e8d4170
NDC67386-130
Product TypeHuman Prescription Drug
Proprietary NameVyepti
Generic NameEptinezumab-jjmr
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-02-21
Marketing CategoryBLA / BLA
Application NumberBLA761119
Labeler NameLundbeck Pharmaceuticals LLC
Substance NameEPTINEZUMAB
Active Ingredient Strength100 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 67386-130-51

1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-51) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67386-130-51 [67386013051]

Vyepti INJECTION
Marketing CategoryBLA
Application NumberBLA761119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-02-21

Drug Details

Active Ingredients

IngredientStrength
EPTINEZUMAB100 mg/mL

OpenFDA Data

SPL SET ID:79065861-6aa5-4d1f-829f-3a6471286b36
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2283054
  • 2283049

  • Trademark Results [Vyepti]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VYEPTI
    VYEPTI
    98008515 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2023-05-23
    VYEPTI
    VYEPTI
    98008498 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2023-05-23
    VYEPTI
    VYEPTI
    88729623 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-17
    VYEPTI
    VYEPTI
    88729621 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-17
    VYEPTI
    VYEPTI
    88729616 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-17
    VYEPTI
    VYEPTI
    88713458 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-03
    VYEPTI
    VYEPTI
    88713452 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-03
    VYEPTI
    VYEPTI
    88713442 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-03
    VYEPTI
    VYEPTI
    88713304 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-03
    VYEPTI
    VYEPTI
    88713252 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-03
    VYEPTI
    VYEPTI
    88713240 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-12-03
    VYEPTI
    VYEPTI
    88705848 not registered Live/Pending
    Lundbeck Seattle BioPharmaceuticals, Inc.
    2019-11-25

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