NDC 50242-070

Gazyva

Obinutuzumab

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

• Product ID: 50242-070_6b5595ca-9d64-476e-9043-a7eeb1ca3858
• NDC: 50242-070
• Product Type: Human Prescription Drug
• Proprietary Name: Gazyva
• Generic Name: Obinutuzumab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-11-01
• Marketing Category: BLA / BLA
• Application Number: BLA125486
• Labeler Name: Genentech, Inc.
• Substance Name: OBINUTUZUMAB
• Active Ingredient Strength: 1000 mg/40mL
• Pharm Classes: CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50242-070-01

1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) > 40 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2013-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-070-01 [50242007001]

Gazyva INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125486
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-01

NDC 50242-070-86 [50242007086]

Gazyva INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125486
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-04

Drug Details

Active Ingredients

Ingredient	Strength
OBINUTUZUMAB	1000 mg/40mL

OpenFDA Data

• SPL SET ID: df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • O43472U9X8
• RxNorm Concept Unique ID - RxCUI:
  • 1442698
  • 1442693

Pharmacological Class

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