NDC 50242-150

OCREVUS

Ocrelizumab

OCREVUS is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Ocrelizumab.

Product ID50242-150_07f1b276-8bb3-4243-8cc7-4c9262e5fdfe
NDC50242-150
Product TypeHuman Prescription Drug
Proprietary NameOCREVUS
Generic NameOcrelizumab
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-03-28
Marketing CategoryBLA / BLA
Application NumberBLA761053
Labeler NameGenentech, Inc.
Substance NameOCRELIZUMAB
Active Ingredient Strength300 mg/10mL
Pharm ClassesCD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Antibodies, Monoclonal [CS],Antibodies, Monoclonal, Humanized [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50242-150-01

1 VIAL, SINGLE-USE in 1 CARTON (50242-150-01) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2017-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-150-01 [50242015001]

OCREVUS INJECTION
Marketing CategoryBLA
Application NumberBLA761053
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-03-28

Drug Details

Active Ingredients

IngredientStrength
OCRELIZUMAB300 mg/10mL

OpenFDA Data

SPL SET ID:9da42362-3bb5-4b83-b4bb-b59fd4e55f0d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1876380
  • 1876385
  • Pharmacological Class

    • CD20-directed Antibody Interactions [MoA]
    • CD20-directed Cytolytic Antibody [EPC]
    • Antibodies
    • Monoclonal [CS]
    • Antibodies
    • Monoclonal
    • Humanized [CS]

    Trademark Results [OCREVUS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OCREVUS
    OCREVUS
    87125369 not registered Live/Pending
    Genentech, Inc.
    2016-08-03
    OCREVUS
    OCREVUS
    86205182 5276659 Live/Registered
    GENENTECH, INC.
    2014-02-26

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