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United States · US · US:71288-144_77b41d41-9975-428a-865a-1593d21b3d99

Docetaxel anhydrous

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc
CountryUS (United States)
ATC codeL01CD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7128814408
    1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08) / 8 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    7128814416
    1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16) / 16 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
699121PHCA
DOCETAXEL ANHYDROUS
RxCUI 1299922
Orange Book
A209634
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": "71288-144_77b41d41-9975-428a-865a-1593d21b3d99",
  "productndc": "71288-144",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209634",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/2ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 24, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "80MG/8ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Aug 24, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "160MG/16ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Aug 24, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOCETAXEL ANHYDROUS",
  "shortage_reason": "Docetaxel Injection",
  "shortage_status": "current",
  "proprietary_name": "Docetaxel anhydrous",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209634",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Docetaxel anhydrous",
  "start_marketing_date": "20180824",
  "active_numerator_strength": "10"
}

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