inlexzo

Generic: gemcitabine intravesical

Labeler: janssen biotech, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inlexzo
Generic Name gemcitabine intravesical
Labeler janssen biotech, inc
Dosage Form SYSTEM
Routes
INTRAVESICAL
Active Ingredients

gemcitabine 225 mg/1

Manufacturer
Janssen Biotech, Inc

Identifiers & Regulatory

Product NDC 57894-225
Product ID 57894-225_3e9075cb-001f-40f0-e063-6394a90aee94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219683
Listing Expiration 2026-12-31
Marketing Start 2025-09-14

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894225
Hyphenated Format 57894-225

Supplemental Identifiers

RxCUI
2723386 2723391
UNII
B76N6SBZ8R
NUI
N0000000233 N0000175595

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 inlexzo (source: ndc)
Generic Name gemcitabine intravesical (source: ndc)
Application Number NDA219683 (source: ndc)
Routes
INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 1 SYSTEM in 1 BOX (57894-225-01)
  • 1 SYSTEM in 1 BOX (57894-225-99)
source: ndc

Packages (2)

57894-225-01 1 SYSTEM in 1 BOX (57894-225-01) 57894-225-99 1 SYSTEM in 1 BOX (57894-225-99)

Ingredients (1)

gemcitabine (225 mg/1)

Linked Drug Pages (1)

INLEXZO ndc-match (0.9)

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"}