NDC 0006-3029

KEYTRUDA

Pembrolizumab

KEYTRUDA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Pembrolizumab.

Product ID0006-3029_064f791c-8110-49ad-9d6b-770dec7ccbd5
NDC0006-3029
Product TypeHuman Prescription Drug
Proprietary NameKEYTRUDA
Generic NamePembrolizumab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-09-04
Marketing CategoryBLA / BLA
Application NumberBLA125514
Labeler NameMerck Sharp & Dohme Corp.
Substance NamePEMBROLIZUMAB
Active Ingredient Strength50 mg/2mL
Pharm ClassesProgrammed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0006-3029-02

1 VIAL in 1 CARTON (0006-3029-02) > 15 mL in 1 VIAL (0006-3029-01)
Marketing Start Date2014-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-3029-02 [00006302902]

KEYTRUDA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125514
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-04
Marketing End Date2015-12-21

NDC 0006-3029-01 [00006302901]

KEYTRUDA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125514
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-04
Marketing End Date2015-12-21

Drug Details

Active Ingredients

IngredientStrength
PEMBROLIZUMAB50 mg/2mL

OpenFDA Data

SPL SET ID:9333c79b-d487-4538-a9f0-71b91a02b287
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1657746
  • 1657750
  • 1657751
  • 1657749
  • Pharmacological Class

    • Programmed Death Receptor-1 Blocking Antibody [EPC]
    • Programmed Death Receptor-1-directed Antibody Interactions [MoA]

    NDC Crossover Matching brand name "KEYTRUDA" or generic name "Pembrolizumab"

    NDCBrand NameGeneric Name
    0006-3026KEYTRUDApembrolizumab
    0006-3029KEYTRUDApembrolizumab

    Trademark Results [KEYTRUDA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KEYTRUDA
    KEYTRUDA
    86177261 not registered Dead/Abandoned
    Merck Sharp & Dohme Corp.
    2014-01-28
    KEYTRUDA
    KEYTRUDA
    86177260 4804821 Live/Registered
    Merck Sharp & Dohme Corp.
    2014-01-28
    KEYTRUDA
    KEYTRUDA
    86177257 not registered Dead/Abandoned
    Merck Sharp & Dohme Corp.
    2014-01-28
    KEYTRUDA
    KEYTRUDA
    86147051 not registered Dead/Abandoned
    Merck Sharp & Dohme Corp.
    2013-12-18
    KEYTRUDA
    KEYTRUDA
    86147047 4804749 Live/Registered
    Merck Sharp & Dohme Corp.
    2013-12-18
    KEYTRUDA
    KEYTRUDA
    86147045 not registered Dead/Abandoned
    Merck Sharp & Dohme Corp.
    2013-12-18
    KEYTRUDA
    KEYTRUDA
    79112065 4263031 Live/Registered
    Merck Sharp & Dohme Corp.
    2011-11-30

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