Docetaxel

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL01CD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143920501
1 VIAL, GLASS in 1 CARTON (0143-9205-01) / 4 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

15H5577CQD

DOCETAXEL

RxCUI 72962

Orange Book

A204490

APAP

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": "0143-9205_5e524fd3-4dc2-4a16-b069-7790c57fcb72",
  "productndc": "0143-9205",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "204490",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 14, 2021"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA204490",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docetaxel",
  "start_marketing_date": "20210114",
  "active_numerator_strength": "20"
}

Related drugs

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