INLEXZO

In shortageOrange BookUNIISPLATC L01BC05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJanssen Biotech, Inc

CountryUS (United States)

ATC codeL01BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5789422599
1 SYSTEM in 1 BOX (57894-225-99)
ndc11
5789422501
1 SYSTEM in 1 BOX (57894-225-01)

Annotations

UNII (FDA Substance ID)

B76N6SBZ8R

GEMCITABINE

RxCUI 12574

Orange Book

N219683

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Gemcitabine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "B76N6SBZ8R",
    "rxcui": "12574",
    "inchikey": "SDUQYLNIPVEERB-QPPQHZFASA-N",
    "display_name": "GEMCITABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVESICAL",
  "spl_meta": {
    "3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb": {
      "match": "brand_token",
      "title": "INLEXZO (GEMCITABINE INTRAVESICAL) SYSTEM [JANSSEN BIOTECH, INC]",
      "spl_version": "1",
      "published_date": "2025-09-15"
    }
  },
  "productid": "57894-225_3e9075cb-001f-40f0-e063-6394a90aee94",
  "productndc": "57894-225",
  "dosage_form": "SYSTEM",
  "orange_book": {
    "appl_no": "219683",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 225MG BASE",
        "product_no": "001",
        "approval_date": "Sep 9, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEMCITABINE",
  "shortage_reason": "Gemcitabine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "INLEXZO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219683",
  "marketing_category": "NDA",
  "nonproprietary_name": "gemcitabine intravesical",
  "start_marketing_date": "20250914",
  "active_numerator_strength": "225"
}

Related drugs

Other records sharing ATC code L01BC05.

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