Package 57894-225-01

Brand: inlexzo

Generic: gemcitabine intravesical
NDC Package

Package Facts

Identity

Package NDC 57894-225-01
Digits Only 5789422501
Product NDC 57894-225
Product ID 57894-225_3e9075cb-001f-40f0-e063-6394a90aee94
Description

1 SYSTEM in 1 BOX (57894-225-01)

Marketing

Marketing Status
Marketed Since 2025-09-14
Brand inlexzo
Generic gemcitabine intravesical
Sample Package No

Linked Drug Pages (1)

INLEXZO ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVESICAL"], "spl_id": "3e9075cb-001f-40f0-e063-6394a90aee94", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["B76N6SBZ8R"], "rxcui": ["2723386", "2723391"], "spl_set_id": ["3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYSTEM in 1 BOX (57894-225-01)", "package_ndc": "57894-225-01", "marketing_start_date": "20250914"}, {"sample": true, "description": "1 SYSTEM in 1 BOX (57894-225-99)", "package_ndc": "57894-225-99", "marketing_start_date": "20250914"}], "brand_name": "INLEXZO", "product_id": "57894-225_3e9075cb-001f-40f0-e063-6394a90aee94", "dosage_form": "SYSTEM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "57894-225", "generic_name": "gemcitabine intravesical", "labeler_name": "Janssen Biotech, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INLEXZO", "active_ingredients": [{"name": "GEMCITABINE", "strength": "225 mg/1"}], "application_number": "NDA219683", "marketing_category": "NDA", "marketing_start_date": "20250914", "listing_expiration_date": "20261231"}