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United States · US · US:0143-9089_7c916380-3ae0-4a64-945d-7b0da46b9715

Doxorubicin Hydrochloride

Orange BookUNIISPLATC L01DB01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL01DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0143908901
    1 VIAL in 1 BOX (0143-9089-01) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
A062975
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "82F2G7BL4E",
    "rxcui": "142433",
    "inchikey": "MWWSFMDVAYGXBV-RUELKSSGSA-N",
    "display_name": "DOXORUBICIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f6508535-e7a7-4e50-8d0c-43deda8d0d08": {
      "match": "brand_token",
      "title": "DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [BLUEPOINT LABORATORIES]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0143-9089_7c916380-3ae0-4a64-945d-7b0da46b9715",
  "productndc": "0143-9089",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "062975",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Mar 17, 1989"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXORUBICIN HYDROCHLORIDE",
  "proprietary_name": "Doxorubicin Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA062975",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxorubicin Hydrochloride",
  "start_marketing_date": "19960501",
  "active_numerator_strength": "2"
}

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