NDC 50242-135

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 ID: 50242-135_07e066f7-664a-4949-9d91-f8a17e022f45
• NDC: 50242-135
• Product Type: Human Prescription Drug
• Proprietary Name: ACTEMRA
• Generic Name: Tocilizumab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-01-08
• Marketing Category: BLA / BLA
• Application Number: BLA125276
• Labeler Name: Genentech, Inc.
• Substance Name: TOCILIZUMAB
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50242-135-01

1 VIAL, SINGLE-USE in 1 BOX (50242-135-01) > 4 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2010-01-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-135-01 [50242013501]

ACTEMRA INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-01-08

NDC 50242-135-04 [50242013504]

ACTEMRA INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125276
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-01-08
• Marketing End Date: 2017-04-06

Drug Details

Active Ingredients

Ingredient	Strength
TOCILIZUMAB	20 mg/mL

OpenFDA Data

• SPL SET ID: 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • I031V2H011
• 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"

NDC	Brand Name	Generic Name
50242-135	ACTEMRA	tocilizumab
50242-136	ACTEMRA	tocilizumab
50242-137	ACTEMRA	tocilizumab
50242-138	Actemra	tocilizumab