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United States · US · US:45963-733_2ad7c99b-8cea-4e22-826f-9e49c90605b6

Doxorubicin hydrochloride

Orange BookUNIISPLATC L01DB01

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeL01DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4596373355
    1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) / 5 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    4596373357
    1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) / 10 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    4596373360
    1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60) / 100 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    4596373368
    1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68) / 25 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
A203622
APAP
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": "45963-733_2ad7c99b-8cea-4e22-826f-9e49c90605b6",
  "productndc": "45963-733",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203622",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Jun 27, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/100ML",
        "product_no": "002",
        "approval_date": "Jun 27, 2014"
      }
    ],
    "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": "ANDA203622",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxorubicin hydrochloride",
  "start_marketing_date": "20141101",
  "active_numerator_strength": "2"
}

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