NDC 44087-3535

BAVENCIO

Avelumab

BAVENCIO is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Emd Serono, Inc.. The primary component is Avelumab.

• Product ID: 44087-3535_184ee357-8deb-45c1-90c3-05785140b34a
• NDC: 44087-3535
• Product Type: Human Prescription Drug
• Proprietary Name: BAVENCIO
• Generic Name: Avelumab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-03-23
• Marketing Category: BLA / BLA
• Application Number: BLA761049
• Labeler Name: EMD Serono, Inc.
• Substance Name: AVELUMAB
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 44087-3535-1

1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44087-3535-1 [44087353501]

BAVENCIO INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA761049
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-23

Drug Details

Active Ingredients

Ingredient	Strength
AVELUMAB	20 mg/mL

OpenFDA Data

• SPL SET ID: 5cd725a1-2fa4-408a-a651-57a7b84b2118
• Manufacturer:
  • EMD Serono, Inc.
• UNII:
  • KXG2PJ551I
• RxNorm Concept Unique ID - RxCUI:
  • 1875542
  • 1875547

Pharmacological Class

• Programmed Death Ligand-1 Blocker [EPC]
• Programmed Death Ligand-1 Antagonists [MoA]
• Programmed Death Ligand-1-directed Antibody Interactions [MoA]
• Antibodies
• Monoclonal [CS]