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United States · US · US:67457-781_fea50522-6e4c-4ae0-81ac-53863693cc06

Docetaxel

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeL01CD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745778108
    1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) / 8 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
15H5577CQD
DOCETAXEL
RxCUI 72962
Orange Book
A208137
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": "67457-781_fea50522-6e4c-4ae0-81ac-53863693cc06",
  "productndc": "67457-781",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "208137",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "160MG/8ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 1, 2019"
      }
    ],
    "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": "ANDA208137",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docetaxel",
  "start_marketing_date": "20190618",
  "active_numerator_strength": "20"
}

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