Package 57894-801-01

Brand: imaavy

Generic: nipocalimab
NDC Package

Package Facts

Identity

Package NDC 57894-801-01
Digits Only 5789480101
Product NDC 57894-801
Product ID 57894-801_347a9376-5865-d57f-e063-6394a90a4ad4
Description

1 VIAL, SINGLE-DOSE in 1 BOX (57894-801-01) / 6.5 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2025-04-29
Brand imaavy
Generic nipocalimab
Sample Package No

Linked Drug Pages (1)

IMAAVY ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "347a9376-5865-d57f-e063-6394a90a4ad4", "openfda": {"unii": ["87M90CV8NC"], "rxcui": ["2712699", "2712706", "2712708", "2712709"], "spl_set_id": ["8886274c-f2b2-48af-85c1-2f90bfe304b8"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (57894-801-01)  / 6.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-801-01", "marketing_start_date": "20250429"}], "brand_name": "IMAAVY", "product_id": "57894-801_347a9376-5865-d57f-e063-6394a90a4ad4", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "57894-801", "generic_name": "nipocalimab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMAAVY", "active_ingredients": [{"name": "NIPOCALIMAB", "strength": "185 mg/mL"}], "application_number": "BLA761430", "marketing_category": "BLA", "marketing_start_date": "20250429", "listing_expiration_date": "20261231"}