Package 57894-350-01
Brand: simponi aria
Generic: golimumabPackage Facts
Identity
Package NDC
57894-350-01
Digits Only
5789435001
Product NDC
57894-350
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
simponi aria
Generic
golimumab
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "3e5ed294-188e-d226-e063-6394a90a5326", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["91X1KLU43E"], "rxcui": ["1431642", "1431647"], "spl_set_id": ["9e260a47-55af-4c92-8d88-a86ccc767fff"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-350-01", "marketing_start_date": "20130719"}, {"sample": true, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-350-89", "marketing_start_date": "20130719"}], "brand_name": "SIMPONI ARIA", "product_id": "57894-350_3e5ed294-188e-d226-e063-6394a90a5326", "dosage_form": "SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "57894-350", "generic_name": "golimumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMPONI ARIA", "active_ingredients": [{"name": "GOLIMUMAB", "strength": "50 mg/4mL"}], "application_number": "BLA125433", "marketing_category": "BLA", "marketing_start_date": "20130719", "listing_expiration_date": "20261231"}