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United States · US · US:46708-810_f8e001f5-441c-47cd-86f6-5d5e3de16bc0

doxorubicin hydrochloride

Orange BookUNIISPLATC L01DB01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeL01DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4670881010
    1 VIAL, SINGLE-DOSE in 1 CARTON (46708-810-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
A219199
ABAB
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": "46708-810_f8e001f5-441c-47cd-86f6-5d5e3de16bc0",
  "productndc": "46708-810",
  "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL",
  "orange_book": {
    "appl_no": "219199",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG/10ML (2MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 27, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/25ML (2MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 27, 2025"
      }
    ],
    "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": "ANDA219199",
  "marketing_category": "ANDA",
  "nonproprietary_name": "doxorubicin hydrochloride",
  "start_marketing_date": "20250627",
  "active_numerator_strength": "2"
}

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