NDC 50242-053

Rituxan

Rituximab

Rituxan is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Rituximab.

Product ID50242-053_02e8a40e-4443-4bd5-acff-ad7f3244d43c
NDC50242-053
Product TypeHuman Prescription Drug
Proprietary NameRituxan
Generic NameRituximab
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1997-11-26
Marketing CategoryBLA / BLA
Application NumberBLA103705
Labeler NameGenentech, Inc.
Substance NameRITUXIMAB
Active Ingredient Strength10 mg/mL
Pharm ClassesCD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50242-053-06

1 VIAL, SINGLE-USE in 1 CARTON (50242-053-06) > 50 mL in 1 VIAL, SINGLE-USE
Marketing Start Date1997-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-053-06 [50242005306]

Rituxan INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103705
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-11-26

Drug Details

Active Ingredients

IngredientStrength
RITUXIMAB10 mg/mL

OpenFDA Data

SPL SET ID:b172773b-3905-4a1c-ad95-bab4b6126563
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1657862
  • 1657868
  • 1657867
  • 1657864
  • Pharmacological Class

    • CD20-directed Antibody Interactions [MoA]
    • CD20-directed Cytolytic Antibody [EPC]

    NDC Crossover Matching brand name "Rituxan" or generic name "Rituximab"

    NDCBrand NameGeneric Name
    50242-051Rituxanrituximab
    50242-053Rituxanrituximab

    Trademark Results [Rituxan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RITUXAN
    RITUXAN
    75238749 2194252 Live/Registered
    BIOGEN MA INC.
    1997-02-10

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