NDC 63459-305

HERZUMA

Trastuzumab

HERZUMA is a Kit in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is .

Product ID63459-305_1319744e-b28e-4f84-80f7-388bb637f5db
NDC63459-305
Product TypeHuman Prescription Drug
Proprietary NameHERZUMA
Generic NameTrastuzumab
Dosage FormKit
Marketing Start Date2018-12-14
Marketing CategoryBLA / BLA
Application NumberBLA761091
Labeler NameCephalon, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63459-305-47

1 KIT in 1 CARTON (63459-305-47) * 50 mL in 1 VIAL, MULTI-DOSE (63459-307-41) * 20 mL in 1 VIAL (63459-221-20)
Marketing Start Date2020-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-305-47 [63459030547]

HERZUMA KIT
Marketing CategoryBLA
Application NumberBLA761091
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-16

Drug Details

OpenFDA Data

SPL SET ID:ae71c003-883a-4cd8-ad50-e8cc9a54e971
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 2107058
  • 2107053
  • NDC Crossover Matching brand name "HERZUMA" or generic name "Trastuzumab"

    NDCBrand NameGeneric Name
    63459-303HERZUMATRASTUZUMAB
    63459-305HERZUMATRASTUZUMAB
    50242-132HerceptinTrastuzumab
    50242-134HerceptinTrastuzumab
    50242-333HerceptinTrastuzumab
    67457-845OGIVRItrastuzumab
    67457-847OGIVRItrastuzumab
    67457-991OGIVRItrastuzumab
    0006-5033Ontruzanttrastuzumab
    0069-0305Trazimera-qyyptrastuzumab

    Trademark Results [HERZUMA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HERZUMA
    HERZUMA
    87692867 5620455 Live/Registered
    CELLTRION, INC.
    2017-11-21
    HERZUMA
    HERZUMA
    79098540 4081964 Live/Registered
    CELLTRION, INC.
    2011-02-18

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