Irinotecan hydrochloride

In shortageOrange BookUNIISPLATC L01CE02

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeL01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4596361451
1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) / 2 mL in 1 VIAL, SINGLE-DOSE
ndc11
4596361455
1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

042LAQ1IIS

IRINOTECAN HYDROCHLORIDE

RxCUI 153329

Orange Book

A078589

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": "45963-614_3bbdb61c-9194-416e-9034-5d2b11b5b8ee",
  "productndc": "45963-614",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078589",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/2ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 27, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/5ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 27, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/25ML (20MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 18, 2015"
      }
    ],
    "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": "ANDA078589",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irinotecan hydrochloride",
  "start_marketing_date": "20150312",
  "active_numerator_strength": "20"
}

Related drugs

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