Irinotecan Hydrochloride

In shortageOrange BookUNIISPLATC L01CE02

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

Identification

ManufacturerArmas Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7248521315
1 VIAL, SINGLE-DOSE in 1 CARTON (72485-213-15) / 15 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

042LAQ1IIS

IRINOTECAN HYDROCHLORIDE

RxCUI 153329

Orange Book

A208718

APAPAP

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": "72485-213_16bc41f7-c83f-473e-bf17-9e6328cecb4b",
  "productndc": "72485-213",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "208718",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/2ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/5ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Dec 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "300MG/15ML (20MG/ML)",
        "product_no": "003",
        "approval_date": "Aug 16, 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": "ANDA208718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irinotecan Hydrochloride",
  "start_marketing_date": "20200904",
  "active_numerator_strength": "20"
}

Related drugs

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