DOCETAXEL

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeL01CD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1672926763
1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE
ndc11
1672926764
1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE
ndc11
1672926765
1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65) / 8 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

699121PHCA

DOCETAXEL ANHYDROUS

RxCUI 1299922

Orange Book

N201195

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Docetaxel Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "699121PHCA",
    "rxcui": "1299922",
    "inchikey": "ZDZOTLJHXYCWBA-VCVYQWHSSA-N",
    "display_name": "DOCETAXEL ANHYDROUS",
    "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": "16729-267_1fbda3cb-1ba1-490d-e063-6294a90a6777",
  "productndc": "16729-267",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "201195",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/0.5ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 8, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG/2ML (40MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 8, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "003",
        "approval_date": "Apr 20, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "004",
        "approval_date": "Apr 20, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "160MG/8ML (20MG/ML)",
        "product_no": "005",
        "approval_date": "Apr 20, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOCETAXEL ANHYDROUS",
  "shortage_reason": "Docetaxel Injection",
  "shortage_status": "current",
  "proprietary_name": "DOCETAXEL",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA201195",
  "marketing_category": "NDA",
  "nonproprietary_name": "docetaxel",
  "start_marketing_date": "20130530",
  "active_numerator_strength": "20"
}

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