NDC 72171-505

GAMIFANT

(emapalumab-lzsg)

GAMIFANT is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Novimmune Sa. The primary component is Emapalumab.

Product ID72171-505_3b952566-94f7-494a-ba9c-044799721b93
NDC72171-505
Product TypeHuman Prescription Drug
Proprietary NameGAMIFANT
Generic Name(emapalumab-lzsg)
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-20
Marketing CategoryBLA / BLA
Application NumberBLA761107
Labeler NameNovImmune SA
Substance NameEMAPALUMAB
Active Ingredient Strength50 mg/10mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 72171-505-01

1 VIAL, SINGLE-USE in 1 CARTON (72171-505-01) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2018-11-20
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72171-505-01 [72171050501]

GAMIFANT INJECTION
Marketing CategoryBLA
Application NumberBLA761107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-20
Marketing End Date2021-11-30

Drug Details

Active Ingredients

IngredientStrength
EMAPALUMAB50 mg/10mL

OpenFDA Data

SPL SET ID:203459a5-9769-44a0-8396-43d110207ba9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2104622
  • 2104611
  • 2104621
  • 2104616
  • NDC Crossover Matching brand name "GAMIFANT" or generic name "(emapalumab-lzsg)"

    NDCBrand NameGeneric Name
    66658-501GAMIFANT(emapalumab-lzsg)
    66658-505GAMIFANT(emapalumab-lzsg)
    66658-510GAMIFANT(emapalumab-lzsg)
    72171-501GAMIFANT(emapalumab-lzsg)
    72171-505GAMIFANT(emapalumab-lzsg)

    Trademark Results [GAMIFANT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GAMIFANT
    GAMIFANT
    87283834 5505933 Live/Registered
    EMACO SA
    2016-12-29

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