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United States · US · US:71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69

daunorubicin hydrochloride

Orange BookUNIISPLATC L01DB02

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01DB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128818205
    10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04)

Annotations

UNII (FDA Substance ID)
UD984I04LZ
DAUNORUBICIN HYDROCHLORIDE
RxCUI 81992
Orange Book
A065035
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "UD984I04LZ",
    "rxcui": "81992",
    "inchikey": "GUGHGUXZJWAIAS-QQYBVWGSSA-N",
    "display_name": "DAUNORUBICIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9705fa12-499e-41a3-8fb4-f6df0858b851": {
      "match": "brand_token",
      "title": "DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.]",
      "spl_version": "13",
      "published_date": "2026-01-20"
    }
  },
  "productid": "71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69",
  "productndc": "71288-182",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "065035",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jan 24, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAUNORUBICIN HYDROCHLORIDE",
  "proprietary_name": "daunorubicin hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA065035",
  "marketing_category": "ANDA",
  "nonproprietary_name": "daunorubicin hydrochloride",
  "start_marketing_date": "20250601",
  "active_numerator_strength": "5"
}

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