Docetaxel

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeL01CD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409506801
1 VIAL, MULTI-DOSE in 1 CARTON (0409-5068-01) / 4 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

15H5577CQD

DOCETAXEL

RxCUI 72962

Orange Book

N022234

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Docetaxel Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "15H5577CQD",
    "rxcui": "72962",
    "inchikey": "XCDIRYDKECHIPE-QHEQPUDQSA-N",
    "display_name": "DOCETAXEL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "81686d37-a13f-46e2-b439-a84eb1433634": {
      "match": "brand_token",
      "title": "DOCETAXEL INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0409-5068_0eff97af-e2cd-46d7-84d3-0445a0910b1a",
  "productndc": "0409-5068",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022234",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/2ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 8, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "80MG/8ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 8, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "160MG/16ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 8, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "004",
        "approval_date": "Jun 23, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "005",
        "approval_date": "Jun 23, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "120MG/6ML (20MG/ML)",
        "product_no": "006",
        "approval_date": "Jun 23, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "160MG/8ML (20MG/ML)",
        "product_no": "007",
        "approval_date": "Jan 24, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOCETAXEL",
  "shortage_reason": "Docetaxel Injection",
  "shortage_status": "current",
  "proprietary_name": "Docetaxel",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022234",
  "marketing_category": "NDA",
  "nonproprietary_name": "DOCETAXEL",
  "start_marketing_date": "20210628",
  "active_numerator_strength": "20"
}

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