NDC 50242-150

OCREVUS

Ocrelizumab

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

• Product ID: 50242-150_07f1b276-8bb3-4243-8cc7-4c9262e5fdfe
• NDC: 50242-150
• Product Type: Human Prescription Drug
• Proprietary Name: OCREVUS
• Generic Name: Ocrelizumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-03-28
• Marketing Category: BLA / BLA
• Application Number: BLA761053
• Labeler Name: Genentech, Inc.
• Substance Name: OCRELIZUMAB
• Active Ingredient Strength: 300 mg/10mL
• Pharm Classes: CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Antibodies, Monoclonal [CS],Antibodies, Monoclonal, Humanized [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50242-150-01

1 VIAL, SINGLE-USE in 1 CARTON (50242-150-01) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2017-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-150-01 [50242015001]

OCREVUS INJECTION

• Marketing Category: BLA
• Application Number: BLA761053
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-28

Drug Details

Active Ingredients

Ingredient	Strength
OCRELIZUMAB	300 mg/10mL

OpenFDA Data

• SPL SET ID: 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • A10SJL62JY
• RxNorm Concept Unique ID - RxCUI:
  • 1876380
  • 1876385

Pharmacological Class

• CD20-directed Antibody Interactions [MoA]
• CD20-directed Cytolytic Antibody [EPC]
• Antibodies
• Monoclonal [CS]
• Antibodies
• Monoclonal
• Humanized [CS]