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United States · US · US:0955-1021_7c9667b2-3981-4256-a6a5-0c862549f837

Docetaxel

In shortageOrange BookUNIISPLATC L01CD02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeL01CD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0955102104
    1 VIAL, GLASS in 1 CARTON (0955-1021-04) / 4 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
15H5577CQD
DOCETAXEL
RxCUI 72962
Orange Book
N020449
AP
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": "0955-1021_7c9667b2-3981-4256-a6a5-0c862549f837",
  "productndc": "0955-1021",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "020449",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "May 14, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "003",
        "approval_date": "Aug 3, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "004",
        "approval_date": "Aug 2, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "160MG/8ML (20MG/ML)",
        "product_no": "005",
        "approval_date": "Apr 13, 2012"
      }
    ],
    "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/4mL",
  "application_number": "NDA020449",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Docetaxel",
  "start_marketing_date": "20101021",
  "active_numerator_strength": "80"
}

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