NDC 64764-300

Entyvio

Vedolizumab

Entyvio is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Vedolizumab.

Product ID64764-300_006da1d8-e01f-48fe-92d8-2f3f6bc16cac
NDC64764-300
Product TypeHuman Prescription Drug
Proprietary NameEntyvio
Generic NameVedolizumab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-05-20
Marketing CategoryBLA / BLA
Application NumberBLA125476
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameVEDOLIZUMAB
Active Ingredient Strength300 mg/5mL
Pharm ClassesIntegrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64764-300-20

1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64764-300-20 [64764030020]

Entyvio INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125476
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-20

Drug Details

Active Ingredients

IngredientStrength
VEDOLIZUMAB300 mg/5mL

OpenFDA Data

SPL SET ID:6e94621c-1a95-4af9-98d1-52b9e6f1949c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1538137
  • 1538142
  • Pharmacological Class

    • Integrin Receptor Antagonist [EPC]
    • Integrin Receptor Antagonists [MoA]

    Trademark Results [Entyvio]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENTYVIO
    ENTYVIO
    85438158 4580498 Live/Registered
    Millennium Pharmaceuticals, Inc.
    2011-10-03

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