DOCIVYX

In shortageOrange BookUNIISPLATC L01CD02

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

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC codeL01CD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383110316
1 VIAL, GLASS in 1 CARTON (83831-103-16) / 16 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

15H5577CQD

DOCETAXEL

RxCUI 72962

Orange Book

N215813

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": {
    "4763744e-360e-4d37-be05-cce4114548cd": {
      "match": "brand_token",
      "title": "DOCIVYX (DOCETAXEL) INJECTION, SOLUTION [AVYXA PHARMA, LLC]",
      "spl_version": "4",
      "published_date": "2025-07-16"
    }
  },
  "productid": "83831-103_6d914dea-626d-4402-8fce-29760fd0e34f",
  "productndc": "83831-103",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215813",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/2ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 22, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80MG/8ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 22, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "160MG/16ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOCETAXEL",
  "shortage_reason": "Docetaxel Injection",
  "shortage_status": "current",
  "proprietary_name": "DOCIVYX",
  "active_ingred_unit": "mg/16mL",
  "application_number": "NDA215813",
  "marketing_category": "NDA",
  "nonproprietary_name": "docetaxel",
  "start_marketing_date": "20240509",
  "active_numerator_strength": "160"
}

Related drugs

Other records sharing ATC code L01CD02.

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