NDC 50242-136

ACTEMRA

Tocilizumab

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

Product ID50242-136_07e066f7-664a-4949-9d91-f8a17e022f45
NDC50242-136
Product TypeHuman Prescription Drug
Proprietary NameACTEMRA
Generic NameTocilizumab
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-01-08
Marketing CategoryBLA / BLA
Application NumberBLA125276
Labeler NameGenentech, Inc.
Substance NameTOCILIZUMAB
Active Ingredient Strength20 mg/mL
Pharm ClassesInterleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50242-136-01

1 VIAL, SINGLE-USE in 1 BOX (50242-136-01) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2010-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-136-04 [50242013604]

ACTEMRA INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryBLA
Application NumberBLA125276
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-08
Marketing End Date2017-04-06

NDC 50242-136-01 [50242013601]

ACTEMRA INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryBLA
Application NumberBLA125276
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-01-08

Drug Details

Active Ingredients

IngredientStrength
TOCILIZUMAB20 mg/mL

OpenFDA Data

SPL SET ID:2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2106075
  • 1441527
  • 2106073
  • 1657980
  • 1657974
  • 1657976
  • 1441530
  • 1657981
  • 1657979
  • 1657982
  • Pharmacological Class

    • Interleukin 6 Receptor Antagonists [MoA]
    • Interleukin-6 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "ACTEMRA" or generic name "Tocilizumab"

    NDCBrand NameGeneric Name
    50242-135ACTEMRAtocilizumab
    50242-136ACTEMRAtocilizumab
    50242-137ACTEMRAtocilizumab
    50242-138Actemratocilizumab

    Trademark Results [ACTEMRA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACTEMRA
    ACTEMRA
    78227672 2984926 Live/Registered
    CHUGAI SEIYAKU KABUSHIKI KAISHA
    2003-03-19

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.