Irinotecan hydrochloride

In shortageOrange BookUNIISPLATC L01CE02

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeL01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808338201
1 VIAL, SINGLE-DOSE in 1 CARTON (68083-382-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

042LAQ1IIS

IRINOTECAN HYDROCHLORIDE

RxCUI 153329

Orange Book

A212993

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": "68083-382_a1ced9af-9117-485c-925d-47f7266bc9df",
  "productndc": "68083-382",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/2ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/5ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 18, 2019"
      }
    ],
    "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/mL",
  "application_number": "ANDA212993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irinotecan hydrochloride",
  "start_marketing_date": "20191118",
  "active_numerator_strength": "20"
}

Related drugs

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