Docetaxel

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeL01CD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4733532340
1 VIAL, GLASS in 1 CARTON (47335-323-40) / 1 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

699121PHCA

DOCETAXEL ANHYDROUS

RxCUI 1299922

Orange Book

N022534

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": "47335-323_9a0d7b91-4324-4e19-9cd8-eb19266e771a",
  "productndc": "47335-323",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022534",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/VIAL",
        "product_no": "001",
        "approval_date": "May 3, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG/VIAL",
        "product_no": "002",
        "approval_date": "May 3, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "004",
        "approval_date": "Jan 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "160MG/8ML (20MG/ML)",
        "product_no": "005",
        "approval_date": "Jan 8, 2019"
      }
    ],
    "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": "NDA022534",
  "marketing_category": "NDA",
  "nonproprietary_name": "Docetaxel",
  "start_marketing_date": "20201126",
  "active_numerator_strength": "20"
}

Related drugs

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