NDC 50242-143

Actemra ACTPen

Tocilizumab

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

Product ID50242-143_07e066f7-664a-4949-9d91-f8a17e022f45
NDC50242-143
Product TypeHuman Prescription Drug
Proprietary NameActemra ACTPen
Generic NameTocilizumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-11-19
Marketing CategoryBLA / BLA
Application NumberBLA125472
Labeler NameGenentech, Inc.
Substance NameTOCILIZUMAB
Active Ingredient Strength180 mg/mL
Pharm ClassesInterleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50242-143-01

1 SYRINGE, GLASS in 1 BOX (50242-143-01) > .9 mL in 1 SYRINGE, GLASS
Marketing Start Date2018-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-143-01 [50242014301]

Actemra ACTPen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125472
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-19

NDC 50242-143-86 [50242014386]

Actemra ACTPen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125472
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-19

Drug Details

Active Ingredients

IngredientStrength
TOCILIZUMAB180 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 ACTPen" or generic name "Tocilizumab"

    NDCBrand NameGeneric Name
    50242-143Actemra ACTPenActemra ACTPen
    50242-135ACTEMRAtocilizumab
    50242-136ACTEMRAtocilizumab
    50242-137ACTEMRAtocilizumab
    50242-138Actemratocilizumab

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