bavencio

Generic: avelumab

Labeler: emd serono, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name bavencio
Generic Name avelumab
Labeler emd serono, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

avelumab 20 mg/mL

Manufacturer
EMD Serono, Inc.

Identifiers & Regulatory

Product NDC 44087-3535
Product ID 44087-3535_8e1f3b1c-5aab-408c-930e-619daa6afa8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761049
Listing Expiration 2026-12-31
Marketing Start 2017-03-23

Pharmacologic Class

Established (EPC)
programmed death ligand-1 blocker [epc]
Mechanism of Action
programmed death ligand-1 antagonists [moa] programmed death ligand-1-directed antibody interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 440873535
Hyphenated Format 44087-3535

Supplemental Identifiers

RxCUI
1875542 1875547
UNII
KXG2PJ551I
NUI
N0000193338 N0000193337 N0000193336 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bavencio (source: ndc)
Generic Name avelumab (source: ndc)
Application Number BLA761049 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

avelumab (20 mg/mL)

Linked Drug Pages (1)

BAVENCIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8e1f3b1c-5aab-408c-930e-619daa6afa8a", "openfda": {"nui": ["N0000193338", "N0000193337", "N0000193336", "M0001357"], "unii": ["KXG2PJ551I"], "rxcui": ["1875542", "1875547"], "spl_set_id": ["5cd725a1-2fa4-408a-a651-57a7b84b2118"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Programmed Death Ligand-1 Blocker [EPC]"], "pharm_class_moa": ["Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["EMD Serono, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "44087-3535-1", "marketing_start_date": "20170323"}], "brand_name": "BAVENCIO", "product_id": "44087-3535_8e1f3b1c-5aab-408c-930e-619daa6afa8a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1 Blocker [EPC]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "product_ndc": "44087-3535", "generic_name": "avelumab", "labeler_name": "EMD Serono, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BAVENCIO", "active_ingredients": [{"name": "AVELUMAB", "strength": "20 mg/mL"}], "application_number": "BLA761049", "marketing_category": "BLA", "marketing_start_date": "20170323", "listing_expiration_date": "20261231"}