NDC 50242-108

Rituxan Hycela

Rituximab And Hyaluronidase

Rituxan Hycela is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Rituximab; Hyaluronidase (human Recombinant).

Product ID50242-108_1d917dd9-67b3-4f8c-8875-d3d383e06362
NDC50242-108
Product TypeHuman Prescription Drug
Proprietary NameRituxan Hycela
Generic NameRituximab And Hyaluronidase
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-06-22
Marketing CategoryBLA / BLA
Application NumberBLA761064
Labeler NameGenentech, Inc.
Substance NameRITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active Ingredient Strength120 mg/mL; U/mL
Pharm ClassesCD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Endoglycosidase [EPC],Glycoside Hydrolases [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50242-108-01

1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) > 11.7 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-108-01 [50242010801]

Rituxan Hycela INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761064
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-22

NDC 50242-108-86 [50242010886]

Rituxan Hycela INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761064
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-23

Drug Details

Active Ingredients

IngredientStrength
RITUXIMAB120 mg/mL

OpenFDA Data

SPL SET ID:3e5b7e82-f018-4eaf-ae78-d6145a906b20
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1927890
  • 1927893
  • 1927885
  • 1927894
  • Pharmacological Class

    • CD20-directed Antibody Interactions [MoA]
    • CD20-directed Cytolytic Antibody [EPC]
    • Endoglycosidase [EPC]
    • Glycoside Hydrolases [CS]

    NDC Crossover Matching brand name "Rituxan Hycela" or generic name "Rituximab And Hyaluronidase"

    NDCBrand NameGeneric Name
    50242-108Rituxan Hycelarituximab and hyaluronidase
    50242-109Rituxan Hycelarituximab and hyaluronidase

    Trademark Results [Rituxan Hycela]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RITUXAN HYCELA
    RITUXAN HYCELA
    87264875 5298229 Live/Registered
    Biogen MA Inc.
    2016-12-12

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