Doxorubicin Hydrochloride

Orange BookUNIISPLATC L01DB01

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc

CountryUS (United States)

ATC codeL01DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0069562905
1 VIAL, SINGLE-DOSE in 1 CARTON (0069-5629-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

82F2G7BL4E

DOXORUBICIN HYDROCHLORIDE

RxCUI 142433

Orange Book

N050629

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": "0069-5629_d31d7f58-66d0-4826-b6b5-5914c031965f",
  "productndc": "0069-5629",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "050629",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Dec 23, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "200MG/100ML",
        "product_no": "002",
        "approval_date": "May 3, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG/75ML",
        "product_no": "003",
        "approval_date": "Mar 28, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXORUBICIN HYDROCHLORIDE",
  "proprietary_name": "Doxorubicin Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA050629",
  "marketing_category": "NDA",
  "nonproprietary_name": "Doxorubicin Hydrochloride",
  "start_marketing_date": "20250331",
  "active_numerator_strength": "2"
}

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