NDC 50242-088

KADCYLA

Ado-trastuzumab Emtansine

KADCYLA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Ado-trastuzumab Emtansine.

Product ID50242-088_025ce8f1-7c1e-4926-9657-daaa1e213dff
NDC50242-088
Product TypeHuman Prescription Drug
Proprietary NameKADCYLA
Generic NameAdo-trastuzumab Emtansine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-02-22
Marketing CategoryBLA / BLA
Application NumberBLA125427
Labeler NameGenentech, Inc.
Substance NameADO-TRASTUZUMAB EMTANSINE
Active Ingredient Strength20 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50242-088-01

1 VIAL, SINGLE-USE in 1 CARTON (50242-088-01) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2013-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-088-01 [50242008801]

KADCYLA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125427
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-22

Drug Details

Active Ingredients

IngredientStrength
ADO-TRASTUZUMAB EMTANSINE20 mg/mL

OpenFDA Data

SPL SET ID:23f3c1f4-0fc8-4804-a9e3-04cf25dd302e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658084
  • 1658087
  • 1658091
  • 1658089
  • NDC Crossover Matching brand name "KADCYLA" or generic name "Ado-trastuzumab Emtansine"

    NDCBrand NameGeneric Name
    50242-087KADCYLAADO-TRASTUZUMAB EMTANSINE
    50242-088KADCYLAADO-TRASTUZUMAB EMTANSINE

    Trademark Results [KADCYLA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KADCYLA
    KADCYLA
    85163874 not registered Dead/Abandoned
    GENENTECH, INC.
    2010-10-28
    KADCYLA
    KADCYLA
    77962556 4347053 Live/Registered
    Genentech, Inc.
    2010-03-18

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