NDC 50242-921

Hemlibra

Emicizumab

Hemlibra is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Emicizumab.

Product ID50242-921_10a84bba-6ac6-4a54-9c2b-55d39a232d59
NDC50242-921
Product TypeHuman Prescription Drug
Proprietary NameHemlibra
Generic NameEmicizumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-11-16
Marketing CategoryBLA / BLA
Application NumberBLA761083
Labeler NameGenentech, Inc.
Substance NameEMICIZUMAB
Active Ingredient Strength150 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50242-921-01

1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) > .4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2017-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-921-01 [50242092101]

Hemlibra INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761083
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-16

Drug Details

Active Ingredients

IngredientStrength
EMICIZUMAB150 mg/mL

OpenFDA Data

SPL SET ID:2483adba-fab6-4d1b-96c5-c195577ed071
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1989804
  • 1989809
  • 1989811
  • 1989799
  • 1989815
  • 1989814
  • 1989817
  • 1989816
  • NDC Crossover Matching brand name "Hemlibra" or generic name "Emicizumab"

    NDCBrand NameGeneric Name
    50242-920Hemlibraemicizumab
    50242-921Hemlibraemicizumab
    50242-922Hemlibraemicizumab
    50242-923Hemlibraemicizumab

    Trademark Results [Hemlibra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HEMLIBRA
    HEMLIBRA
    87449931 5722898 Live/Registered
    CHUGAI SEIYAKU KABUSHIKI KAISHA
    2017-05-15
    HEMLIBRA
    HEMLIBRA
    86652355 4892349 Live/Registered
    CHUGAI SEIYAKU KABUSHIKI KAISHA
    2015-06-04

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