Docetaxel

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL01CD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315590331
1 VIAL in 1 CARTON (23155-903-31) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

15H5577CQD

DOCETAXEL

RxCUI 72962

Orange Book

A216677

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": "23155-903_459836aa-017b-4ba5-a69d-d16824f719fd",
  "productndc": "23155-903",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216677",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 28, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 28, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "160MG/8ML (20MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 26, 2024"
      }
    ],
    "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": "ANDA216677",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docetaxel",
  "start_marketing_date": "20241215",
  "active_numerator_strength": "20"
}

Related drugs

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