Irinotecan Hydrochloride

In shortageOrange BookUNIISPLATC L01CE02

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeL01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5074240205
1 VIAL, GLASS in 1 CARTON (50742-402-05) / 5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

042LAQ1IIS

IRINOTECAN HYDROCHLORIDE

RxCUI 153329

Orange Book

A206935

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Irinotecan Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "042LAQ1IIS",
    "rxcui": "153329",
    "inchikey": "KLEAIHJJLUAXIQ-JDRGBKBRSA-N",
    "display_name": "IRINOTECAN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5e1fdcaa-918f-4cd8-9c7a-4c538d866198": {
      "match": "brand_token",
      "title": "IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]",
      "spl_version": "27",
      "published_date": "2026-04-08"
    }
  },
  "productid": "50742-402_3c841594-8a93-4728-b184-0f4bfac73390",
  "productndc": "50742-402",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206935",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/2ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "May 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/5ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "May 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IRINOTECAN HYDROCHLORIDE",
  "shortage_reason": "Irinotecan Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Irinotecan Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA206935",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irinotecan Hydrochloride",
  "start_marketing_date": "20170605",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L01CE02.

Access this data programmatically

Query Irinotecan Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs